glimepiride and Cardiovascular Diseases

glimepiride has been researched along with Cardiovascular Diseases in 27 studies

glimepiride: structure given in first source

Cardiovascular Diseases: Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

Research

Studies (27)

Authors

Clinical Trials (10)

Trial Overview

Trial Outcomes

CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study

Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint. (NCT01243424)
Timeframe: Baseline

Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks

The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint. (NCT01243424)
Timeframe: Baseline and week 208

Change From Baseline to Final Visit in Creatinine

Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)

Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)

Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)

Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Change From Baseline to Final Visit in Triglycerides

Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)

Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study

Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint. (NCT01243424)
Timeframe: Baseline

Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase

The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase. (NCT01243424)
Timeframe: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)

Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase

The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase. (NCT01243424)
Timeframe: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)

Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up

Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint. (NCT01243424)
Timeframe: 433 weeks

Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events

"Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:~CV death (including fatal stroke and fatal MI)~non-fatal MI~non-fatal stroke~hospitalisation for unstable angina pectoris~TIA~hospitalisation for heart failure~hospitalisation for coronary revascularisation procedures (CABG, PCI)" (NCT01243424)
Timeframe: From start of the treatment until 7 days after the end of treatment, up to 433 weeks

Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE

Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE

Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

The First 3-point Major Adverse Cardiovascular Events (3P-MACE)

The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

The First 4-point (4P)- MACE

The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events

"Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:~CV death (including fatal stroke and fatal MI)~non-fatal MI~non-fatal stroke~hospitalisation for unstable angina pectoris~Transient ischaemic attack (TIA)~hospitalisation for heart failure~hospitalisation for coronary revascularisation procedures (CABG, PCI)" (NCT01243424)
Timeframe: From start of the treatment until 7 days after the end of treatment, up to 433 weeks

Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol

Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Percentage of Participants With Transition in Albuminuria Classes

Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented. (NCT01243424)
Timeframe: Baseline and week 432

Change in Body Weight From Baseline to Year 3

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

Change in DI30/DG30 Ratio From Baseline to Endpoint

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

Change in Disposition Index From Baseline to Endpoint

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

Change in Fasting Plasma Glucose From Baseline to Endpoint

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

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

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

Change in HbA1c From Baseline to Endpoint

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

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

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

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

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

Change in HbA1c From Baseline to Year 3

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

Change in HOMA-B From Baseline to Endpoint

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

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

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

Diastolic Blood Pressure at Year 3

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

Disposition Index at Year 3

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

Fasting Plasma Glucose at Year 3

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

Fasting Proinsulin/Insulin Ratio at Year 3

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

Heart Rate at Year 3

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

High-density Lipoprotein (HDL) Cholesterol at Year 3

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

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

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

Hypoglycemia Rate Per Year

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

Hypoglycemia Rate Per Year in Period III

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

Postprandial (2 Hours) Plasma Glucose at Year 3

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

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

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

Systolic Blood Pressure at Year 3

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

Time to Treatment Failure

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

Total Cholesterol at Year 3

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

Triglycerides at Year 3

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

Number of Patients With Treatment Failure

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

Primary Major Macrovascular Events

Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene. (NCT00032487)
Timeframe: Post baseline time to the first major macrovascular event up to 82 months

Secondary Endpoint

New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality. (NCT00032487)
Timeframe: Post baseline time to first event up to 82 months

Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline

The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM) (NCT01524705)
Timeframe: At baseline, 6 months of intervention

HbA1C Levels

% of glycosylated hemoglobin in whole blood at 26 weeks (NCT01524705)
Timeframe: Baseline vs 26 weeks

Number of Participants With Hypoglycemia

Severe hypoglycemia-documented glucose <50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel. (NCT01524705)
Timeframe: 26 weeks

Weight Change During Trial

Weight in kg at 26 weeks minus weight at baseline. (NCT01524705)
Timeframe: Baseline vs 26 weeks

Reviews

5 reviews available for glimepiride and Cardiovascular Diseases

Trials

11 trials available for glimepiride and Cardiovascular Diseases

Other Studies

11 other studies available for glimepiride and Cardiovascular Diseases