Non-Insulin-Dependent Diabetes Mellitus
Conditions
Keywords
type 2 diabetes, rosiglitazone, metformin, glimepiride, glycemia
Brief summary
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).
Interventions
DRUGrosiglitazone-metformin fixed dose combination
DRUGmetformin + glimepiride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 40 to 80 years * Diagnosis of type 2 diabetes mellitus for at least 6 months * Body mass index (BMI) ≥25kg/m2 * 7%≥HbA1c ≤ 9% at visit 2 * Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1 * Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures * Written informed consent
Exclusion criteria
* Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening * Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure * Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis * Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1 * Subjects with a history of severe hypoglycaemia * Anemia defined by haemoglobin concentration \<11.0g/dL for males or \<10.0g/dL for females * Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females * Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase \>2.5 times the upper limit of the normal reference range) * Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction * Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids * Female who are lactating, pregnant, or planning to become pregnant * Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...) * Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study * Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance * Subjects not willing to comply with the procedures described in this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| HbA1c (Glycosylated Hemoglobin) | Baseline and 12 weeks | Uncontrolled HbA1c\>8.5%. HbA1c and fasting blood glucose taken at hospital |
| 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | Baseline and 12 weeks | 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. |
| Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
| Glycaemia According to CGMS (Diurnal), mg/dL | Baseline and 12 weeks | 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. |
| Glycaemia According to CGMS (Dawn), mg/dL | Baseline and 12 weeks | 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. |
| Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | Baseline and 12 weeks | 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. |
| Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | Baseline and 12 weeks | 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. |
| Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | Baseline and 12 weeks | 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. |
| Glycaemia According to CGMS (MAGE), mg/dL | Baseline and 12 weeks | 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. |
| Glycaemia According to CGMS (Nocturnal), mg/dL | Baseline and 12 weeks | 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. |
| Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline and 12 weeks | Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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:
* from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal
* from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal
* from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal
* from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal. | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive any treatment | 0 | 1 |
| Overall Study | Took Avandamet instead of Glim/Met | 0 | 1 |
Baseline characteristics
| Characteristic | Glimepiride/Metformin | Total | Avandamet® (Rosiglitazone/Metformin) |
|---|---|---|---|
| Age Continuous | 62.2 years STANDARD_DEVIATION 6.6 | 60.5 years STANDARD_DEVIATION 8.7 | 59 years STANDARD_DEVIATION 10.3 |
| Body Mass Index (BMI) | 30.1 kg/m² STANDARD_DEVIATION 4.8 | 31.2 kg/m² STANDARD_DEVIATION 5.8 | 32.2 kg/m² STANDARD_DEVIATION 6.6 |
| HbA1c | 7.8 percentage STANDARD_DEVIATION 0.52 | 7.8 percentage STANDARD_DEVIATION 0.5 | 7.8 percentage STANDARD_DEVIATION 0.51 |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Outcome results
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.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 17.31 Hours | Standard Error 6.25 |
| Avandamet® (Rosiglitazone/Metformin) | Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 15.30 Hours | Standard Error 6.1 |
| Glimepiride/Metformin | Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 17.53 Hours | Standard Error 6.84 |
| Glimepiride/Metformin | Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 10.83 Hours | Standard Error 6.06 |
Comparison: Statistical analysis was based off of week 12 results.p-value: 0.06495% CI: [-0.32, 10.36]ANCOVA
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 3.91 Episodes | Standard Error 2.03 |
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 5.36 Episodes | Standard Error 2.67 |
| Glimepiride/Metformin | Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 4.05 Episodes | Standard Error 2.51 |
| Glimepiride/Metformin | Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 5.90 Episodes | Standard Error 3.01 |
Comparison: Statistical analysis was based off of week 12 results.p-value: 0.92395% CI: [-3.37, 2.85]ANCOVA
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | Baseline | 361.9 pg/mL | Standard Error 207.53 |
| Avandamet® (Rosiglitazone/Metformin) | 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | 12 weeks | 373.5 pg/mL | Standard Error 180.15 |
| Glimepiride/Metformin | 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | Baseline | 325.1 pg/mL | Standard Error 148.2 |
| Glimepiride/Metformin | 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate | 12 weeks | 320.4 pg/mL | Standard Error 84.74 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0.51 Hours | Standard Error 1.06 |
| Avandamet® (Rosiglitazone/Metformin) | Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.14 Hours | Standard Error 0.47 |
| Glimepiride/Metformin | Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0 Hours | Standard Error 0 |
| Glimepiride/Metformin | Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.08 Hours | Standard Error 0.26 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0.85 Hours | Standard Error 1.54 |
| Avandamet® (Rosiglitazone/Metformin) | Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.64 Hours | Standard Error 1.97 |
| Glimepiride/Metformin | Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0.24 Hours | Standard Error 0.45 |
| Glimepiride/Metformin | Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.41 Hours | Standard Error 0.8 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 11.28 Hours | Standard Error 8.67 |
| Avandamet® (Rosiglitazone/Metformin) | Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 6.39 Hours | Standard Error 5.3 |
| Glimepiride/Metformin | Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | Baseline | 12.35 Hours | Standard Error 7.13 |
| Glimepiride/Metformin | Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 4.23 Hours | Standard Error 5.32 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0.50 Episodes | Standard Error 1.02 |
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.14 Episodes | Standard Error 0.45 |
| Glimepiride/Metformin | Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0 Episodes | Standard Error 0 |
| Glimepiride/Metformin | Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.1 Episodes | Standard Error 0.32 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0.64 Episodes | Standard Error 0.87 |
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.50 Episodes | Standard Error 1.36 |
| Glimepiride/Metformin | Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 0.30 Episodes | Standard Error 0.63 |
| Glimepiride/Metformin | Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 0.80 Episodes | Standard Error 1.6 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 4.00 Episodes | Standard Error 1.95 |
| Avandamet® (Rosiglitazone/Metformin) | Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 5.00 Episodes | Standard Error 2.98 |
| Glimepiride/Metformin | Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | Baseline | 3.55 Episodes | Standard Error 1.34 |
| Glimepiride/Metformin | Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment | 12 weeks | 2.95 Episodes | Standard Error 2.83 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | Baseline | 905.6 mg/dL | Standard Error 728.2 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | 12 weeks | 534.5 mg/dL | Standard Error 307.5 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | Baseline | 850.1 mg/dL | Standard Error 601.2 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL | 12 weeks | 355.0 mg/dL | Standard Error 338.2 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Dawn), mg/dL | Baseline | 145.0 mg/dL | Standard Error 37.23 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Dawn), mg/dL | 12 weeks | 130.6 mg/dL | Standard Error 21.31 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Dawn), mg/dL | 12 weeks | 124.7 mg/dL | Standard Error 20.26 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Dawn), mg/dL | Baseline | 138.6 mg/dL | Standard Error 23.44 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Diurnal), mg/dL | Baseline | 162.1 mg/dL | Standard Error 43.1 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Diurnal), mg/dL | 12 weeks | 139.1 mg/dL | Standard Error 15.23 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Diurnal), mg/dL | Baseline | 158.7 mg/dL | Standard Error 27.4 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Diurnal), mg/dL | 12 weeks | 130.13 mg/dL | Standard Error 21.17 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (MAGE), mg/dL | 12 weeks | 44.2 mg/dL | Standard Error 18.3 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (MAGE), mg/dL | Baseline | 75.1 mg/dL | Standard Error 22.5 |
| Glimepiride/Metformin | Glycaemia According to CGMS (MAGE), mg/dL | Baseline | 61.6 mg/dL | Standard Error 13.7 |
| Glimepiride/Metformin | Glycaemia According to CGMS (MAGE), mg/dL | 12 weeks | 50.8 mg/dL | Standard Error 16.4 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Nocturnal), mg/dL | Baseline | 148.4 mg/dL | Standard Error 42.94 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Nocturnal), mg/dL | 12 weeks | 130.2 mg/dL | Standard Error 21.97 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Nocturnal), mg/dL | Baseline | 140.4 mg/dL | Standard Error 30.18 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Nocturnal), mg/dL | 12 weeks | 126.3 mg/dL | Standard Error 21.76 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | Baseline | 522.8 mg/dL | Standard Error 271.6 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | 12 weeks | 356.9 mg/dL | Standard Error 138.4 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | Baseline | 443.0 mg/dL | Standard Error 157.9 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL | 12 weeks | 362.7 mg/dL | Standard Error 177.3 |
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.
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | Baseline | 1428.2 mg/dL | Standard Error 971.3 |
| Avandamet® (Rosiglitazone/Metformin) | Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | 12 weeks | 891.4 mg/dL | Standard Error 342.4 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | Baseline | 1293.1 mg/dL | Standard Error 636.3 |
| Glimepiride/Metformin | Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL | 12 weeks | 717.7 mg/dL | Standard Error 460.6 |
Secondary
HbA1c (Glycosylated Hemoglobin)
Uncontrolled HbA1c\>8.5%. HbA1c and fasting blood glucose taken at hospital
Time frame: Baseline and 12 weeks
Population: ITT (randomized)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avandamet® (Rosiglitazone/Metformin) | HbA1c (Glycosylated Hemoglobin) | Baseline | 7.8 Percentage | Standard Error 0.65 |
| Avandamet® (Rosiglitazone/Metformin) | HbA1c (Glycosylated Hemoglobin) | 12 weeks | 7.4 Percentage | Standard Error 0.62 |
| Glimepiride/Metformin | HbA1c (Glycosylated Hemoglobin) | Baseline | 7.7 Percentage | Standard Error 0.5 |
| Glimepiride/Metformin | HbA1c (Glycosylated Hemoglobin) | 12 weeks | 7.1 Percentage | Standard Error 0.79 |