glimepiride and Hypoglycemia

glimepiride has been researched along with Hypoglycemia in 106 studies

glimepiride: structure given in first source

Hypoglycemia: A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH.

Research

Studies (106)

Authors

Clinical Trials (37)

Trial Overview

Trial Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52

To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52

Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52

Change From Baseline in Total Body Weight at Week 52

To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52

Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156

Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. (NCT02419612)
Timeframe: At Week 156

Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52

Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. (NCT02419612)
Timeframe: At Week 52

Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period. (NCT02419612)
Timeframe: Up to Week 156

Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period. (NCT02419612)
Timeframe: Up to Week 52

Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model. (NCT02419612)
Timeframe: Up to Week 156

Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 104 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 52 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 104 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)

The change in body weight from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 104 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 104 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)

This change from baseline reflects the Week 104 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)

This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)

This change from baseline reflects the Week 52 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)

This change from baseline reflects the Week 104 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 104

Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)

This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 26

Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)

This change from baseline reflects the Week 52 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)

BMD at the total hip was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 26

Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 52

Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)

BMD at the distal forearm was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications. (NCT02033889)
Timeframe: Baseline and Week 104

Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104

Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 106

Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104

Per protocol participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 104

Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 26

Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Up to Week 52

Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104

Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26

Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52

Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 104

Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 26

Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Week 52

Time to Glycemic Rescue Therapy at Week 26

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. (NCT02033889)
Timeframe: Week 26

Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach)

Pharmacokinetic samples were collected at approximately 24 hours following the prior day's dose and before administration of the current day's dose. The lower limit of quantitation (LLOQ) was 0.500 mg/mL. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02033889)
Timeframe: Pre-dose and/or 60 minutes post-dose on Weeks 6, 12, 18, and 30

2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104

This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Baseline and week 104

Body Weight Change From Baseline at Week 104

This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications. (NCT00622284)
Timeframe: Baseline and week 104

Body Weight Change From Baseline at Week 52

This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications. (NCT00622284)
Timeframe: Baseline and week 52

Change in Baseline Lipid Parameter Cholesterol at Week 104

(NCT00622284)
Timeframe: Baseline and week 104

Change in Baseline Lipid Parameter HDL at Week 104

(NCT00622284)
Timeframe: Baseline and week 104

Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104

(NCT00622284)
Timeframe: Baseline and week 104

Change in Baseline Lipid Parameter Triglyceride at Week 104

(NCT00622284)
Timeframe: Baseline and week 104

Fasting Plasma Glucose (FPG) Change From Baseline at Week 104

This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Baseline and week 104

Fasting Plasma Glucose (FPG) Change From Baseline at Week 52

This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Baseline and week 52

HbA1c Change at Week 104

The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule. (NCT00622284)
Timeframe: Baseline and week 104

HbA1c Change at Week 12

(NCT00622284)
Timeframe: Baseline and week 12

HbA1c Change at Week 16

(NCT00622284)
Timeframe: Baseline and week 16

HbA1c Change at Week 28

(NCT00622284)
Timeframe: Baseline and week 28

HbA1c Change at Week 4

Difference of base percent value [Week x(%) - baseline (%)] (NCT00622284)
Timeframe: Baseline and week 4

HbA1c Change at Week 40

(NCT00622284)
Timeframe: Baseline and week 40

HbA1c Change at Week 52

(NCT00622284)
Timeframe: Baseline and week 52

HbA1c Change at Week 65

(NCT00622284)
Timeframe: Baseline and week 65

HbA1c Change at Week 78

(NCT00622284)
Timeframe: Baseline and week 78

HbA1c Change at Week 8

(NCT00622284)
Timeframe: Baseline and week 8

HbA1c Change at Week 91

(NCT00622284)
Timeframe: Baseline and week 91

HbA1c Change From Baseline at Week 104

This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Baseline and week 104

HbA1c Change From Baseline at Week 52

This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Baseline and week 52

Incidence of Hypoglycaemic Events up to 104 Weeks

A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L) (NCT00622284)
Timeframe: Week 104

Incidence of Hypoglycaemic Events up to 52 Weeks

A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L) (NCT00622284)
Timeframe: Week 52

Percentage of Patients With HbA1c <6.5% at Week 104

The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Week 104

Percentage of Patients With HbA1c <6.5% at Week 52

The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Week 52

Percentage of Patients With HbA1c <7.0% at Week 104

The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Week 104

Percentage of Patients With HbA1c <7.0% at Week 52

The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. (NCT00622284)
Timeframe: Week 52

Percentage of Patients With HbA1c Lowering by 0.5% at Week 104

Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104 (NCT00622284)
Timeframe: Week 104

Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12

The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. (NCT01026194)
Timeframe: at Week 0 and Week 12

Change From Baseline in Fasting Plasma Glucose at Week 12

The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. (NCT01026194)
Timeframe: at Week 0 and Week 12

Change From Baseline in HbA1c at Week 12

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. (NCT01026194)
Timeframe: at Week 0 and Week 12

Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12

The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. (NCT01026194)
Timeframe: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12

Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12

The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. (NCT00974090)
Timeframe: at Week 0 and Week 12

Change From Baseline in Fasting Plasma Glucose at Week 12

The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. (NCT00974090)
Timeframe: at Week 0 and Week 12

Change From Baseline in HbA1c at Week 12

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. (NCT00974090)
Timeframe: at Week 0 and Week 12

Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12

The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. (NCT00974090)
Timeframe: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint. (NCT00971243)
Timeframe: Baseline and Week 24

Change in HbA1c From Baseline to Week 24

The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate. (NCT00971243)
Timeframe: Baseline and Week 24

Change in HbA1c From Baseline to Week 104

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Baseline, Week 104

Change in HbA1c From Baseline to Week 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52

Percent Change in Body Weight From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52

Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52

The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52

Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)

Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52

Change From Baseline to Week 52 in HbA1c.

Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52.

Change From Baseline to Week 52 in Insulin

Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52

Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]

β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52

Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%

Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set. (NCT01006603)
Timeframe: From week 0 to week 52

Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.

"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set." (NCT01006603)
Timeframe: From week 0 to week 52.

Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.

"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.~Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration." (NCT01006603)
Timeframe: From week 0 to week 52.

Change in Body Weight From Baseline to Year 3

Change in Body weight from baseline to Year 3. (NCT00359762)
Timeframe: Baseline, Year 3 in Period II

Change in DI30/DG30 Ratio From Baseline to Endpoint

Change in DI30/DG30 ratio from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Change in Disposition Index From Baseline to Endpoint

Change in disposition index from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Change in Fasting Plasma Glucose From Baseline to Endpoint

Change in fasting plasma glucose from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.

Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Change in HbA1c From Baseline to Endpoint

Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study). (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III

Change in HbA1c from baseline to Year 2. (NCT00359762)
Timeframe: Baseline in Period III, Year 2 in Period III

Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III

Change in HbA1c from baseline to Year 2. (NCT00359762)
Timeframe: Baseline in Period III, Year 2 in Period III

Change in HbA1c From Baseline to Year 3

Change in HbA1c from baseline to Year 3. (NCT00359762)
Timeframe: Baseline, Year 3 in Period II

Change in HOMA-B From Baseline to Endpoint

Change in HOMA-B from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint

Change from baseline in postprandial (2 hours) plasma glucose to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Diastolic Blood Pressure at Year 3

Diastolic Blood pressure at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Disposition Index at Year 3

Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175). (NCT00359762)
Timeframe: Year 3 in Period II

Fasting Plasma Glucose at Year 3

Fasting plasma glucose at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Fasting Proinsulin/Insulin Ratio at Year 3

Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Heart Rate at Year 3

Heart rate at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

High-density Lipoprotein (HDL) Cholesterol at Year 3

HDL Cholesterol at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3

HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175). (NCT00359762)
Timeframe: Year 3 in Period II

Hypoglycemia Rate Per Year

All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)

Hypoglycemia Rate Per Year in Period III

All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination. (NCT00359762)
Timeframe: Start of Period III to end of study

Postprandial (2 Hours) Plasma Glucose at Year 3

Postprandial (2 hours) plasma glucose at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3

DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L). (NCT00359762)
Timeframe: Year 3 in Period II

Systolic Blood Pressure at Year 3

Systolic Blood pressure at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Time to Treatment Failure

Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)

Total Cholesterol at Year 3

Total Cholesterol at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Triglycerides at Year 3

Triglycerides at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Number of Patients With Treatment Failure

Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)

Number of Hypoglycemic Events (HAE) Episodes Per Participant

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported. (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14

Number of Participants With Abnormal Laboratory Values

Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test). (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14

Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers. (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14

Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14

(NCT01517373)
Timeframe: Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)

Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12

(NCT01517373)
Timeframe: Baseline (Day 1), Week 2, 4, 6, 8, 12

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12

HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported. (NCT01517373)
Timeframe: Baseline (Day 1), Week 12

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8

HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported. (NCT01517373)
Timeframe: Baseline (Day 1), Week 2, 4, 6, 8

Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data

Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec). (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14

Number of Participants With Increase/Decrease From Baseline Vital Signs Data

Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion. (NCT01517373)
Timeframe: Baseline (Day 1) up to Week 14

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT01517373)
Timeframe: Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)

Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12

HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent. (NCT01517373)
Timeframe: Week 12

Number of Hypoglycemic Events (HAE) Episodes Per Participant

A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14

Number of Participants With Abnormal Laboratory Values

Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test). (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14

Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode

A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers. (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14

Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14

(NCT01475461)
Timeframe: Baseline (Day 1), Week 2, 4, 8 , 12 , 14

Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14

(NCT01475461)
Timeframe: Baseline (Day 1), Week 1, 2, 4, 8, 12, 14

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12

HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported. (NCT01475461)
Timeframe: Baseline (Day 1), Week 12

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8

HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported. (NCT01475461)
Timeframe: Baseline(Day 1), Week 2, 4, 8

Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data

Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec). (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14

Number of Participants With Increase/Decrease From Baseline Vital Signs Data

Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion. (NCT01475461)
Timeframe: Baseline (Day 1) up to Week 14

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT01475461)
Timeframe: Baseline (Day 1) up to 14 days after last dose (up to 101 days)

Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12

HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent. (NCT01475461)
Timeframe: Week 12

Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30

Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. (NCT01189890)
Timeframe: Baseline and Week 30

LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30

Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG. (NCT01189890)
Timeframe: Baseline and Week 30

LS Mean Change From Baseline in Participant Body Weight at Week 30

Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30. (NCT01189890)
Timeframe: Baseline and Week 30

Number of Participants Discontinuing Study Treatment Due to An AE

"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered." (NCT01189890)
Timeframe: Up to Week 30

Number of Participants Experiencing An Adverse Event (AE)

"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered." (NCT01189890)
Timeframe: Up to Week 30

Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30

Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms. (NCT01189890)
Timeframe: Up to Week 30

Percentage of Participants With HbA1c <6.5% at Week 30

Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. (NCT01189890)
Timeframe: Week 30

Percentage of Participants With HbA1c <7.0% at Week 30

Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. (NCT01189890)
Timeframe: Week 30

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate. (NCT01075282)
Timeframe: Baseline, 52 weeks

Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate. (NCT01075282)
Timeframe: Baseline, 26 weeks, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index

Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks for Body Weight

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension

The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living

"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate." (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception

The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey

The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate

Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes

Amylase (total and pancreas-derived) and lipase concentrations were measured. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin

(NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure

Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Change From Baseline to 52 and 78 Weeks in Glucagon Concentration

Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 52, and 78 weeks

Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 52, and 78 weeks

Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate

Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT01075282)
Timeframe: Baseline, 26, 52, and 78 weeks

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks

Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks

Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks

Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks

Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks

The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)

LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized. (NCT01075282)
Timeframe: Baseline, 26, 52, 78, and 83 weeks

Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks

A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: 26, 52, and 78 weeks

Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks

Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01075282)
Timeframe: Baseline through 26, 52, and 78 weeks

Change From Baseline in Body Weight at 52 W

(NCT01183104)
Timeframe: Baseline and 52 W

Change From Baseline in HbA1c at 52 W

(NCT01183104)
Timeframe: Baseline and 52 W

Change From Baseline in HOMA-β at 52 W

β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] (NCT01183104)
Timeframe: Baseline and 52 W

Change From Baseline in Insulin/Proinsulin Ratio at 52 W

(NCT01183104)
Timeframe: Baseline and 52 W

Number of Participants With Hypoglycaemia

(NCT01183104)
Timeframe: From baseline to 52 W

The Number of Participants Achieving HbA1c < 6.9 %

(NCT01183104)
Timeframe: 52 W

Change in Body Weight at Week 104

Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension) (NCT00294723)
Timeframe: week 0, week 104

Change in Body Weight at Week 156

Change in body weight from baseline (week 0) to 156 weeks (NCT00294723)
Timeframe: week 0, week 156

Change in Body Weight at Week 52

Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period) (NCT00294723)
Timeframe: week 0, week 52

Change in Fasting Plasma Glucose at Week 104

Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension) (NCT00294723)
Timeframe: week 0, week 104

Change in Fasting Plasma Glucose at Week 156

Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks (NCT00294723)
Timeframe: week 0, week 156

Change in Fasting Plasma Glucose at Week 52

Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period) (NCT00294723)
Timeframe: week 0, week 52

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension) (NCT00294723)
Timeframe: week 0, week 104

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks (NCT00294723)
Timeframe: week 0, week 156

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period) (NCT00294723)
Timeframe: week 0, week 52

Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104

Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. (NCT00294723)
Timeframe: week 0, week 104

Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156

Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. (NCT00294723)
Timeframe: week 0, week 156

Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52

Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. (NCT00294723)
Timeframe: week 0, week 52

Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104

Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three. (NCT00294723)
Timeframe: week 0, week 104

Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156

Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three. (NCT00294723)
Timeframe: week 0, week 156

Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52

Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three. (NCT00294723)
Timeframe: week 0, week 52

Hypoglycaemic Episodes

Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. (NCT00294723)
Timeframe: weeks 0-104

Hypoglycaemic Episodes

Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL. (NCT00294723)
Timeframe: weeks 104-195

Change From Baseline in Body Weight at Week 30

Change from baseline at Week 30 was defined as Week 30 minus Week 0. (NCT00701090)
Timeframe: Week 0 to Week 30

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30

Change from baseline at Week 30 was defined as Week 30 minus Week 0. (NCT00701090)
Timeframe: Week 0 to Week 30

Change From Baseline in HbA1c at Week 30

Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent. (NCT00701090)
Timeframe: Week 0 to Week 30

Percent of Patients With A1C <6.5% at Week 30

(NCT00701090)
Timeframe: Week 30

Percent of Patients With A1C <7.0% at Week 30

(NCT00701090)
Timeframe: Week 30

Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30

(NCT00701090)
Timeframe: Week 0 to Week 30

Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)

This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis). (NCT00740051)
Timeframe: Baseline and week 18

HbA1c Change From Baseline at Week 18 (Final Analysis)

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report. (NCT00740051)
Timeframe: Baseline and week 18

HbA1c Change From Baseline at Week 18 (Interim Analysis)

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Baseline and week 18

Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)

Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Week 18

Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)

Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Week 18

Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)

Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. (NCT00740051)
Timeframe: Week 18

The Change in FPG From Baseline by Visit Over Time

This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG. (NCT00740051)
Timeframe: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52

The Change in HbA1c From Baseline by Visit Over Time

HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent. (NCT00740051)
Timeframe: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52

Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12

Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases. (NCT00907881)
Timeframe: Baseline and Week 12

Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores

Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa. (NCT00907881)
Timeframe: Week 12

Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)

Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa. (NCT00907881)
Timeframe: Week 12

Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)

Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12. (NCT00907881)
Timeframe: Week 12

Change From Baseline in A1C at Week 24

Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. (NCT00106704)
Timeframe: Baseline and 24 Weeks

Change From Baseline in FPG at Week 24

The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. (NCT00106704)
Timeframe: Baseline and 24 Weeks

Reviews

12 reviews available for glimepiride and Hypoglycemia

Trials

62 trials available for glimepiride and Hypoglycemia