glimepiride and Hyperglycemia

glimepiride has been researched along with Hyperglycemia in 38 studies

glimepiride: structure given in first source

Hyperglycemia: Abnormally high BLOOD GLUCOSE level.

Research

Studies (38)

Authors

Clinical Trials (11)

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

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

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

Change From Baseline to Week 52 in HbA1c.

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

Change From Baseline to Week 52 in Insulin

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

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

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

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

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

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

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

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

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

Change 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 From Baseline in Adiponectin.

The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Diastolic Blood Pressure.

The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in E-Selectin.

The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (0.30%).

The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (0.60%)

The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (1.20).

The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (12.00).

The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (3.00).

The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (30.00).

The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (6.00).

The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (60.00).

The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Fasting Glucose.

The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Fasting Intact Proinsulin.

The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Glycosylated Hemoglobin.

The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).

The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High Sensitivity C-reactive Protein (Original).

The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High-Density Lipoprotein Cholesterol.

The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.

The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Low-Density Lipoprotein Cholesterol.

The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Low-Density Lipoprotein Subfractions.

The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Matrix Metallo Proteinase-9.

The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Nitrotyrosine.

The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Platelet Function.

The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Soluble CD40 Ligand.

The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Soluble Intracellular Adhesion Molecule.

The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Soluble Vascular Cell Adhesion Molecule.

The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Systolic Blood Pressure.

The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Thromboxane B2.

The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Triglycerides.

The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Von-Willebrand Factor.

The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Intake of Study Medication Greater Than 80% and Less Than 120%.

The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.

The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Reviews

2 reviews available for glimepiride and Hyperglycemia

Trials

17 trials available for glimepiride and Hyperglycemia

Other Studies

19 other studies available for glimepiride and Hyperglycemia