glimepiride and Body Weight

glimepiride has been researched along with Body Weight in 43 studies

glimepiride: structure given in first source

Body Weight: The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.

Research

Studies (43)

Authors

Clinical Trials (26)

Trial Overview

Trial Outcomes

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis. (NCT00849056)
Timeframe: Baseline and Week 52

Change From Baseline in Body Weight at Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. (NCT00849056)
Timeframe: Baseline and Week 156

Change From Baseline in Body Weight at Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. (NCT00849056)
Timeframe: Baseline and Week 52

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156

The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. (NCT00849056)
Timeframe: Baseline and Week 156

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

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. (NCT00849056)
Timeframe: Baseline and Week 52

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and =250 mg/dL between >=Week 4 and =8.5% and a <=0.5% reduction from Baseline between >=Week 12 and =8.5% between >=Week 24 and =8.0% between >= Week 48 and NCT00849056)
Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Change From Baseline in HbA1c at Weeks 104 and 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00849056)
Timeframe: Baseline and Weeks 104 and 156

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed. (NCT00849056)
Timeframe: Week 156

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed. (NCT00849056)
Timeframe: Week 52

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. (NCT00838916)
Timeframe: Baseline and Week 52

Change From Baseline in Body Weight at Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. (NCT00838916)
Timeframe: Baseline and Week 156

Change From Baseline in Body Weight at Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy. (NCT00838916)
Timeframe: Baseline and Week 52

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. (NCT00838916)
Timeframe: Baseline and Week 156

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

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy. (NCT00838916)
Timeframe: Baseline and Week 52

Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52

A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment. (NCT00838916)
Timeframe: Baseline and Week 52

Change From Baseline in HbA1c at Week 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00838916)
Timeframe: Baseline and Week 156

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and =250 mg/dL between >=Week 4 and =8.5% and a <=0.5% reduction from Baseline between >=Week 12 and =8.5% between >=Week 24 and =8.0% between >= Week 48 and NCT00838916)
Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Albiglutide Plasma Concentrations at Week 8 and Week 24

Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations. (NCT00838916)
Timeframe: Weeks 8 and 24

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed. (NCT00838916)
Timeframe: Week 156

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed. (NCT00838916)
Timeframe: Week 52

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. (NCT00849017)
Timeframe: Baseline and Week 52

Change From Baseline in Body Weight at Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. (NCT00849017)
Timeframe: Baseline and Week 156

Change From Baseline in Body Weight at Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. (NCT00849017)
Timeframe: Baseline and Week 52

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156

The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. (NCT00849017)
Timeframe: Baseline and Week 156

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

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. (NCT00849017)
Timeframe: Baseline and Week 52

Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC

Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00849017)
Timeframe: Baseline and Week 52

Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC

Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00849017)
Timeframe: Baseline and Week 52

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and =250 mg/dL between >=Week 4 and =8.5% and a <=0.5% reduction from Baseline between >=Week 12 and =8.5% between >=Week 24 and =8.0% between >= Week 48 and NCT00849017)
Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Albiglutide Plasma Concentration at Weeks 8 and 24

Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study. (NCT00849017)
Timeframe: Weeks 8 and 24

Change From Baseline in HbA1c at Weeks 104 and 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00849017)
Timeframe: Baseline and Weeks 104 and 156

Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC

Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00849017)
Timeframe: Baseline and Week 52

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed. (NCT00849017)
Timeframe: Week 156

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed. (NCT00849017)
Timeframe: Week 52

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint. (NCT00839527)
Timeframe: Baseline and Week 52

Change From Baseline in Body Weight at Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region. (NCT00839527)
Timeframe: Baseline and Week 52

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

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region. (NCT00839527)
Timeframe: Baseline and Week 52

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and =250 mg/dL between >=Week 4 and =8.5% and a <=0.5% reduction from Baseline between >=Week 12 and =8.5% between >=Week 24 and =8.0% between >= Week 48 and NCT00839527)
Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Change From Baseline in Body Weight at Week 104 and Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00839527)
Timeframe: Baseline, Week 104, and Week 156

Change From Baseline in FPG at Week 104 and Week 156

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00839527)
Timeframe: Baseline, Week 104, and Week 156

Change From Baseline in HbA1c at Week 104 and Week 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00839527)
Timeframe: Baseline, Week 104, and Week 156

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed. (NCT00839527)
Timeframe: Week 156

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52. (NCT00839527)
Timeframe: Week 52

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. (NCT00838903)
Timeframe: Baseline and Week 104

Change From Baseline in Body Weight at Week 104

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region. (NCT00838903)
Timeframe: Baseline and Week 104

Change From Baseline in Body Weight at Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00838903)
Timeframe: Baseline and Week 156

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

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region. (NCT00838903)
Timeframe: Baseline and Week 104

Change From Baseline in FPG at Week 156

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. (NCT00838903)
Timeframe: Baseline and Week 156

Change From Baseline in HbA1c at Week 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed . (NCT00838903)
Timeframe: Baseline and Week 156

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and =250 mg/dL between >=Week 4 and =8.5% and a <=0.5% reduction from Baseline between >=Week 12 and =8.5% between >=Week 24 and =8.0% between >= Week 48 and NCT00838903)
Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed. (NCT00838903)
Timeframe: Week 104

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed. (NCT00838903)
Timeframe: Week 156

Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise

To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24. (NCT00680745)
Timeframe: Baseline to Week 24

Adjusted Mean Change in Body Weight

To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride. (NCT00680745)
Timeframe: Baseline to Week 24

Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2

To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride. (NCT00680745)
Timeframe: Baseline to Week 24

Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride. (NCT00680745)
Timeframe: Baseline to Week 24

Adjusted Mean Change in HbA1c Levels

To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period. (NCT00680745)
Timeframe: Baseline to Week 24

Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride. (NCT00680745)
Timeframe: At Week 24

Change in Percent of Blood Glucose (BG) Within Target

Percent of BG between 70 and 180 mg/dL, as measured using Continuous Glucose Monitor (CGM) (NCT03199638)
Timeframe: baseline vs. at 3 months

Change in the Mean Amplitude of Glycemic Excursions (MAGE)

MAGE describes the average amplitude of glycemic variations measured using continuous glucose monitoring (CGM) (NCT03199638)
Timeframe: before vs. at 3 months

HbA1c, Glycated Hemoglobin

change in glycated hemoglobin (NCT03199638)
Timeframe: baseline vs. at 3 months

Insulin Dose

Change in insulin dose (Units/kg/day) used at home (NCT03199638)
Timeframe: baseline vs. at 3 months

Insulin Sensitivity Score (ISS)

Change in insulin sensitivity score, determined using SEARCH ISS model published equation: logeIS = 4.64725 - 0.02032 × (waist, cm) - 0.09779 × (HbA1c, %) - 0.00235 × (Triglycerides, mg/dL). The range of ISS scores is between 1-15. Higher scores imply a better insulin sensistivity. (NCT03199638)
Timeframe: baseline vs. at 3 months

Percent Blood Glucose (BG) >180

Change in Percent of BG above 180 mg, as determined using Continuous Glucose Monitor (CGM) (NCT03199638)
Timeframe: baseline vs. at 3 months

Percent of BG <70 mg/dL

Change in Percent of BG below 70 mg/dL, as determined by Continuous Glucose Monitor (CGM) (NCT03199638)
Timeframe: baseline vs. at 3 months

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

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

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

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

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

Percent Change in Triglycerides From Baseline to Week 52

The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

Percentage of Patients With HbA1c <7% at Week 52

The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage. (NCT01137812)
Timeframe: Week 52

Change in 2-hour Post-prandial Glucose From Baseline to Week 26

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

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 or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

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

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

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 or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

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 active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

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 or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

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

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

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 or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

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 active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

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 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

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 or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Triglycerides From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

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 between each canagliflozin or sitagliptin group and placebo. (NCT01106677)
Timeframe: Week 26

Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose 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. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

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

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. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Change in HbA1c From Baseline to Week 26 (Main Study)

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. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

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

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

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

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. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Body Weight From Baseline to Week 26 (Main Study)

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 percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

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

The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

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

The table below shows the least-squares (LS) mean percent change in HDL-C 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 percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Percent Change in Triglycerides From Baseline to Week 26 (Main Study)

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 percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)

The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Week 26

Percentage of Patients With HbA1c <7% at Week 26 (Main Study)

The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01081834)
Timeframe: Week 26

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. (NCT01106625)
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. (NCT01106625)
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. (NCT01106625)
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 percent change. (NCT01106625)
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 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
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 percent change. (NCT01106625)
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. (NCT01106625)
Timeframe: Week 26

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 Week 30

Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline) (NCT00993187)
Timeframe: Baseline and Week 30

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

Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline). (NCT00993187)
Timeframe: Baseline and Week 30

Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30

HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline). (NCT00993187)
Timeframe: Baseline and Week 30

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 30 weeks

Number of Participants Who Experienced at Least One Adverse Event (AE)

An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 32 weeks

Percentage of Participants With HbA1C < 7.0% at Week 30

HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). (NCT00993187)
Timeframe: Week 30

Percentage of Participants With One or More Episodes of Hypoglycemia

Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. (NCT00993187)
Timeframe: Up to Week 30

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

Reviews

3 reviews available for glimepiride and Body Weight

Trials

28 trials available for glimepiride and Body Weight

Other Studies

12 other studies available for glimepiride and Body Weight