glimepiride and Weight Loss

glimepiride has been researched along with Weight Loss in 12 studies

glimepiride: structure given in first source

Weight Loss: Decrease in existing BODY WEIGHT.

Research

Studies (12)

Authors

Clinical Trials (10)

Trial Overview

Trial Outcomes

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 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 in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Change in HbA1c From Baseline to Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Body Weight From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Triglycerides From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Percentage of Patients With HbA1c <7% at Week 26

The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01106651)
Timeframe: Week 26

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 in Beta-cell Function at Week 104

"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00318461)
Timeframe: week 0, week 104

Change in Beta-cell Function at Week 26

"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00318461)
Timeframe: week 0, week 26

Change in Body Weight at Week 104

Change in body weight from baseline (week 0) to 104 weeks (end of treatment) (NCT00318461)
Timeframe: week 0, week 104

Change in Body Weight at Week 26

Change in body weight from baseline (week 0) to 26 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 26

Change in Fasting Plasma Glucose (FPG) at Week 104

Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment) (NCT00318461)
Timeframe: week 0, week 104

Change in Fasting Plasma Glucose (FPG) at Week 26

Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 26

Change in Glycosylated A1c (HbA1c) at Week 104

Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 104

Change in Glycosylated A1c (HbA1c) at Week 26

Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation) (NCT00318461)
Timeframe: week 0, week 26

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three. (NCT00318461)
Timeframe: week 0, week 104

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three. (NCT00318461)
Timeframe: week 0, week 26

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three." (NCT00318461)
Timeframe: week 0, week 104

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three." (NCT00318461)
Timeframe: week 0, week 26

Hypoglycaemic Episodes at Week 104

Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). 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 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00318461)
Timeframe: weeks 0-104

Hypoglycaemic Episodes at Week 26

Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). 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 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00318461)
Timeframe: weeks 0-26

Change in Beta-cell Function

"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)." (NCT00614120)
Timeframe: week 0, week 16

Change in Body Weight

Change in body weight from baseline (week 0) to 16 weeks (end of treatment) (NCT00614120)
Timeframe: week 0, week 16

Change in Fasting Lipid Profile, APO-B

Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment). (NCT00614120)
Timeframe: week 0, week 16

Change in Glycosylated Haemoglobin A1c (HbA1c)

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment). (NCT00614120)
Timeframe: week 0, week 16

Change in Self-measured Fasting Plasma Glucose

Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary. (NCT00614120)
Timeframe: week 0, week 16

7-point Self-measured Plasma Glucose Profiles

Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16). (NCT00614120)
Timeframe: week 0, 8, 12 and 16

Change in Fasting Lipid Profile

"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:~Total Cholesterol (TC)~Low-density Lipoprotein-cholesterol (LDL-C)~Very Low-density Lipoprotein-cholesterol (VLDL-C)~High-density Lipoprotein-cholesterol (HDL-C)~Triglyceride (TG)~Free Fatty Acid (FFA)" (NCT00614120)
Timeframe: week 0, week 16

Hypoglycaemic Episodes

Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). 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 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00614120)
Timeframe: weeks 0-16

Reviews

1 review available for glimepiride and Weight Loss

Trials

7 trials available for glimepiride and Weight Loss

Other Studies

4 other studies available for glimepiride and Weight Loss