Trial Outcomes & Findings for 24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes (NCT NCT00318656)

NCT ID: NCT00318656

Last Updated: 2009-05-07

Results Overview

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2009-05-07

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	12	11
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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.	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.
Overall Study Took Avandamet instead of Glim/Met	0	1
Overall Study Did not receive any treatment	0	1

Baseline Characteristics

24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

Baseline characteristics by cohort

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.	Total n=21 Participants Total of all reporting groups
Age Continuous	59 years STANDARD_DEVIATION 10.3 • n=5 Participants	62.2 years STANDARD_DEVIATION 6.6 • n=7 Participants	60.5 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Body Mass Index (BMI)	32.2 kg/m² STANDARD_DEVIATION 6.6 • n=5 Participants	30.1 kg/m² STANDARD_DEVIATION 4.8 • n=7 Participants	31.2 kg/m² STANDARD_DEVIATION 5.8 • n=5 Participants
HbA1c	7.8 percentage STANDARD_DEVIATION 0.51 • n=5 Participants	7.8 percentage STANDARD_DEVIATION 0.52 • n=7 Participants	7.8 percentage STANDARD_DEVIATION 0.50 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
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	17.53 Hours Standard Error 6.84
Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment 12 weeks	15.30 Hours Standard Error 6.10	10.83 Hours Standard Error 6.06

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment Baseline	3.91 Episodes Standard Error 2.03	4.05 Episodes Standard Error 2.51
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment 12 weeks	5.36 Episodes Standard Error 2.67	5.90 Episodes Standard Error 3.01

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
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	12.35 Hours Standard Error 7.13
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 5.30	4.23 Hours Standard Error 5.32

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment Baseline	4.00 Episodes Standard Error 1.95	3.55 Episodes Standard Error 1.34
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	2.95 Episodes Standard Error 2.83

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
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	0.24 Hours Standard Error 0.45
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	0.41 Hours Standard Error 0.80

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment Baseline	0.64 Episodes Standard Error 0.87	0.30 Episodes Standard Error 0.63
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment 12 weeks	0.50 Episodes Standard Error 1.36	0.80 Episodes Standard Error 1.60

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
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	0 Hours Standard Error 0
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	0.08 Hours Standard Error 0.26

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment Baseline	0.50 Episodes Standard Error 1.02	0 Episodes Standard Error 0
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment 12 weeks	0.14 Episodes Standard Error 0.45	0.1 Episodes Standard Error 0.32

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
HbA1c (Glycosylated Hemoglobin) Baseline	7.8 Percentage Standard Error 0.65	7.7 Percentage Standard Error 0.50
HbA1c (Glycosylated Hemoglobin) 12 weeks	7.4 Percentage Standard Error 0.62	7.1 Percentage Standard Error 0.79

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate Baseline	361.9 pg/mL Standard Error 207.53	325.1 pg/mL Standard Error 148.2
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate 12 weeks	373.5 pg/mL Standard Error 180.15	320.4 pg/mL Standard Error 84.74

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Glycaemia According to CGMS (Nocturnal), mg/dL 12 weeks	130.2 mg/dL Standard Error 21.97	126.3 mg/dL Standard Error 21.76
Glycaemia According to CGMS (Nocturnal), mg/dL Baseline	148.4 mg/dL Standard Error 42.94	140.4 mg/dL Standard Error 30.18

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Glycaemia According to CGMS (Diurnal), mg/dL Baseline	162.1 mg/dL Standard Error 43.1	158.7 mg/dL Standard Error 27.40
Glycaemia According to CGMS (Diurnal), mg/dL 12 weeks	139.1 mg/dL Standard Error 15.23	130.13 mg/dL Standard Error 21.17

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Glycaemia According to CGMS (Dawn), mg/dL Baseline	145.0 mg/dL Standard Error 37.23	138.6 mg/dL Standard Error 23.44
Glycaemia According to CGMS (Dawn), mg/dL 12 weeks	130.6 mg/dL Standard Error 21.31	124.7 mg/dL Standard Error 20.26

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
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	1293.1 mg/dL Standard Error 636.3
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	717.7 mg/dL Standard Error 460.6

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL Baseline	522.8 mg/dL Standard Error 271.6	443.0 mg/dL Standard Error 157.9
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	362.7 mg/dL Standard Error 177.3

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL Baseline	905.6 mg/dL Standard Error 728.2	850.1 mg/dL Standard Error 601.2
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	355.0 mg/dL Standard Error 338.2

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT (randomized)

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.

Outcome measures

Measure	Avandamet® (Rosiglitazone/Metformin) n=11 Participants 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.	Glimepiride/Metformin n=10 Participants 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.
Glycaemia According to CGMS (MAGE), mg/dL Baseline	75.1 mg/dL Standard Error 22.5	61.6 mg/dL Standard Error 13.7
Glycaemia According to CGMS (MAGE), mg/dL 12 weeks	44.2 mg/dL Standard Error 18.3	50.8 mg/dL Standard Error 16.4

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER