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| ID | Type | Description | Link |
|---|---|---|---|
| AVAF4003 |
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A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone-metformin fixed dose combination | Drug | |||
| metformin + glimepiride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22775317 | Derived | Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avandamet® (Rosiglitazone/Metformin) | Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily. |
| FG001 | Glimepiride/Metformin | Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avandamet® (Rosiglitazone/Metformin) | Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized): This Intent-to-treat (ITT) population included all subjects who had been randomised, who had received at least one dose of study medication, and for whom at least one efficacy criteria on treatment period was available. The ITT population was the primary population for the efficacy analysis. | Posted | Mean | Standard Error | Hours | Baseline and 12 weeks |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C471074 | rosiglitazone-metformin combination |
| D008687 | Metformin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| Baseline and 12 weeks |
| Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | Baseline and 12 weeks |
| HbA1c (Glycosylated Hemoglobin) | Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital | Baseline and 12 weeks |
| 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | 8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time. | Baseline and 12 weeks |
| Glycaemia According to CGMS (Nocturnal), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time. | Baseline and 12 weeks |
| Glycaemia According to CGMS (Diurnal), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight. | Baseline and 12 weeks |
| Glycaemia According to CGMS (Dawn), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia "at dawn" measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time. | Baseline and 12 weeks |
| Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system. | Baseline and 12 weeks |
| Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system. | Baseline and 12 weeks |
| Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system. | Baseline and 12 weeks |
| Glycaemia According to CGMS (MAGE), mg/dL | Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days. | Baseline and 12 weeks |
| Glimepiride/Metformin |
Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI: A key index for relating a person's body weight to their height. The body mass index (BMI) is a person's weight in kilograms (kg) divided by their height in meters (m) squared. | Mean | Standard Deviation | kg/m² |
|
| HbA1c | HbA1c reflects the mean level of glycaemia over time. | Mean | Standard Deviation | percentage |
|
| OG001 | Glimepiride/Metformin | Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:
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| Primary | Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Episodes | Baseline and 12 weeks |
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| Secondary | Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Hours | Baseline and 12 weeks |
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| Secondary | Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Episodes | Baseline and 12 weeks |
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| Secondary | Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Hours | Baseline and 12 weeks |
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| Secondary | Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Episodes | Baseline and 12 weeks |
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| Secondary | Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Hours | Baseline and 12 weeks |
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| Secondary | Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. | ITT (randomized) | Posted | Mean | Standard Error | Episodes | Baseline and 12 weeks |
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| Secondary | HbA1c (Glycosylated Hemoglobin) | Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital | ITT (randomized) | Posted | Mean | Standard Error | Percentage | Baseline and 12 weeks |
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| Secondary | 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | 8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time. | ITT (randomized) | Posted | Mean | Standard Error | pg/mL | Baseline and 12 weeks |
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| Secondary | Glycaemia According to CGMS (Nocturnal), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
|
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| Secondary | Glycaemia According to CGMS (Diurnal), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
|
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|
| Secondary | Glycaemia According to CGMS (Dawn), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia "at dawn" measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
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| Secondary | Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
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| Secondary | Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
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| Secondary | Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
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| Secondary | Glycaemia According to CGMS (MAGE), mg/dL | Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days. | ITT (randomized) | Posted | Mean | Standard Error | mg/dL | Baseline and 12 weeks |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004700 | Endocrine System Diseases |