glimepiride has been researched along with Mycoses in 1 studies
glimepiride: structure given in first source
Mycoses: Diseases caused by FUNGI.
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Gallo, S | 1 |
Charbonnel, B | 1 |
Goldman, A | 1 |
Shi, H | 1 |
Huyck, S | 1 |
Darekar, A | 1 |
Lauring, B | 1 |
Terra, SG | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monothe[NCT02033889] | Phase 3 | 621 participants (Actual) | Interventional | 2013-12-13 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | Percent A1C (Mean) |
---|---|
Placebo/Glimepiride | -0.58 |
Ertugliflozin 5 mg | -0.60 |
Ertugliflozin 15 mg | -0.89 |
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
Intervention | Percent A1C (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.03 |
Ertugliflozin 5 mg | -0.73 |
Ertugliflozin 15 mg | -0.91 |
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
Intervention | Percent A1C (Mean) |
---|---|
Placebo/Glimepiride | -0.68 |
Ertugliflozin 5 mg | -0.72 |
Ertugliflozin 15 mg | -0.96 |
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
Intervention | Kilograms (Mean) |
---|---|
Placebo/Glimepiride | -0.18 |
Ertugliflozin 5 mg | -3.77 |
Ertugliflozin 15 mg | -3.63 |
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
Intervention | Kilograms (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -1.33 |
Ertugliflozin 5 mg | -3.01 |
Ertugliflozin 15 mg | -2.93 |
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
Intervention | Kilograms (Mean) |
---|---|
Placebo/Glimepiride | 0.07 |
Ertugliflozin 5 mg | -3.23 |
Ertugliflozin 15 mg | -3.35 |
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
Intervention | mg/dL (Mean) |
---|---|
Placebo/Glimepiride | -10.9 |
Ertugliflozin 5 mg | -18.2 |
Ertugliflozin 15 mg | -28.2 |
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
Intervention | mg/dL (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.85 |
Ertugliflozin 5 mg | -27.54 |
Ertugliflozin 15 mg | -39.10 |
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
Intervention | mg/dL (Mean) |
---|---|
Placebo/Glimepiride | -12.0 |
Ertugliflozin 5 mg | -22.4 |
Ertugliflozin 15 mg | -35.2 |
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
Intervention | mmHg (Mean) |
---|---|
Placebo/Glimepiride | -0.46 |
Ertugliflozin 5 mg | -2.36 |
Ertugliflozin 15 mg | -1.52 |
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
Intervention | mmHg (Least Squares Mean) |
---|---|
Placebo/Glimepiride | 0.23 |
Ertugliflozin 5 mg | -1.59 |
Ertugliflozin 15 mg | -2.19 |
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
Intervention | mmHg (Mean) |
---|---|
Placebo/Glimepiride | 0.38 |
Ertugliflozin 5 mg | -1.40 |
Ertugliflozin 15 mg | -1.19 |
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
Intervention | mmHg (Mean) |
---|---|
Placebo/Glimepiride | 0.05 |
Ertugliflozin 5 mg | -3.61 |
Ertugliflozin 15 mg | -3.13 |
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
Intervention | mmHg (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.70 |
Ertugliflozin 5 mg | -4.38 |
Ertugliflozin 15 mg | -5.20 |
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
Intervention | mmHg (Mean) |
---|---|
Placebo/Glimepiride | 0.65 |
Ertugliflozin 5 mg | -2.63 |
Ertugliflozin 15 mg | -4.28 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -1.23 |
Ertugliflozin 5 mg | -1.11 |
Ertugliflozin 15 mg | -0.96 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | 0.09 |
Ertugliflozin 5 mg | -0.19 |
Ertugliflozin 15 mg | -0.13 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -1.18 |
Ertugliflozin 5 mg | -1.72 |
Ertugliflozin 15 mg | -2.02 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | 0.06 |
Ertugliflozin 5 mg | -0.15 |
Ertugliflozin 15 mg | -0.13 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.40 |
Ertugliflozin 5 mg | -0.10 |
Ertugliflozin 15 mg | 0.30 |
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
Intervention | Percentage change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | 0.22 |
Ertugliflozin 5 mg | -0.01 |
Ertugliflozin 15 mg | 0.12 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.63 |
Ertugliflozin 5 mg | -0.55 |
Ertugliflozin 15 mg | -0.36 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.44 |
Ertugliflozin 5 mg | -0.59 |
Ertugliflozin 15 mg | -0.39 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.69 |
Ertugliflozin 5 mg | -0.49 |
Ertugliflozin 15 mg | -0.44 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.10 |
Ertugliflozin 5 mg | -0.28 |
Ertugliflozin 15 mg | 0.07 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.82 |
Ertugliflozin 5 mg | -1.04 |
Ertugliflozin 15 mg | -1.32 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | 10.8 |
Ertugliflozin 5 mg | 51.9 |
Ertugliflozin 15 mg | 80.2 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | 19.29 |
Ertugliflozin 5 mg | 26.94 |
Ertugliflozin 15 mg | 32.53 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | 15.54 |
Ertugliflozin 5 mg | 34.36 |
Ertugliflozin 15 mg | 41.57 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | 19.38 |
Ertugliflozin 5 mg | 10.11 |
Ertugliflozin 15 mg | 24.21 |
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
Intervention | Percent Change (Mean) |
---|---|
Placebo/Glimepiride | 24.50 |
Ertugliflozin 5 mg | 8.41 |
Ertugliflozin 15 mg | 19.79 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | -0.98 |
Ertugliflozin 5 mg | 0.28 |
Ertugliflozin 15 mg | 0.14 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | 0.5 |
Ertugliflozin 5 mg | 0.8 |
Ertugliflozin 15 mg | 0.5 |
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
Intervention | Percent change (Mean) |
---|---|
Placebo/Glimepiride | 10.12 |
Ertugliflozin 5 mg | 8.16 |
Ertugliflozin 15 mg | 5.46 |
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
Intervention | Percent Change (Mean) |
---|---|
Placebo/Glimepiride | 8.11 |
Ertugliflozin 5 mg | 11.09 |
Ertugliflozin 15 mg | 2.48 |
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
Intervention | Percent change (Least Squares Mean) |
---|---|
Placebo/Glimepiride | -0.58 |
Ertugliflozin 5 mg | -0.40 |
Ertugliflozin 15 mg | -0.64 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 2.4 |
Ertugliflozin 5 mg | 3.4 |
Ertugliflozin 15 mg | 3.9 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 77.5 |
Ertugliflozin 5 mg | 70.5 |
Ertugliflozin 15 mg | 75.6 |
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
Intervention | Percentage of participants (Number) |
---|---|
Placebo/Glimepiride | 24.4 |
Ertugliflozin 5 mg | 11.1 |
Ertugliflozin 15 mg | 10.7 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 17.7 |
Ertugliflozin 5 mg | 2.9 |
Ertugliflozin 15 mg | 1.5 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 17.2 |
Ertugliflozin 5 mg | 4.3 |
Ertugliflozin 15 mg | 1.5 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 7.2 |
Ertugliflozin 5 mg | 10.6 |
Ertugliflozin 15 mg | 12.2 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 2.9 |
Ertugliflozin 5 mg | 8.7 |
Ertugliflozin 15 mg | 12.2 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 11.0 |
Ertugliflozin 5 mg | 10.6 |
Ertugliflozin 15 mg | 14.6 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 19.1 |
Ertugliflozin 5 mg | 24.6 |
Ertugliflozin 15 mg | 33.7 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 15.8 |
Ertugliflozin 5 mg | 35.3 |
Ertugliflozin 15 mg | 40.0 |
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
Intervention | Percentage of Participants (Number) |
---|---|
Placebo/Glimepiride | 30.6 |
Ertugliflozin 5 mg | 34.8 |
Ertugliflozin 15 mg | 36.6 |
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
Intervention | Days (Median) |
---|---|
Placebo/Glimepiride | 105 |
Ertugliflozin 5 mg | 112 |
Ertugliflozin 15 mg | 139 |
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
Intervention | ng/mL (Mean) | |||||
---|---|---|---|---|---|---|
Week 6:Pre-dose | Week 12:Pre-dose | Week 12:60 mins post-dose | Week 18:Pre-dose | Week 18:60 mins post-dose | Week 30:Pre-dose | |
Ertugliflozin 15 mg | 38.38 | 29.23 | 228.13 | 24.46 | 214.96 | 30.55 |
Ertugliflozin 5 mg | 14.89 | 12.34 | 74.84 | 9.91 | 74.39 | 12.66 |
Placebo/Glimepiride | NA | NA | NA | 0.01 | 0.01 | 0.15 |
1 trial available for glimepiride and Mycoses
Article | Year |
---|---|
Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial.
Topics: Aged; Blood Glucose; Bone Density; Bridged Bicyclo Compounds, Heterocyclic; Diabetes Mellitus, Type | 2019 |