Trial Outcomes & Findings for An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients (NCT NCT01453049)

Results Overview

Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

86 participants

Primary outcome timeframe

Baseline (Week 0) and Week 24

Results posted on

2012-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rosiglitazone+Glimepiride FDC Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Glimepiride Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Overall Study STARTED	42	44
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	41	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Rosiglitazone+Glimepiride FDC Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Glimepiride Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Overall Study Protocol Violation	2	5
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawn When Sponsor Terminated Study	35	36
Overall Study Withdrawal by Subject	1	0
Overall Study Randomized in Error	1	0

Baseline Characteristics

An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Total n=73 Participants Total of all reporting groups
Age Continuous	53.6 Years STANDARD_DEVIATION 10.54 • n=5 Participants	52.2 Years STANDARD_DEVIATION 8.57 • n=7 Participants	52.9 Years STANDARD_DEVIATION 9.52 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	23 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 24

Population: Full Analysis Set (FAS): all randomized participants who received \>=1 dose of study medication and had \>=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	-1.47 Percent of total hemoglobin Standard Deviation 1.227	-1.75 Percent of total hemoglobin Standard Deviation 1.078

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24

Population: FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-0.877 Millimoles per liter (mmol/L) Standard Deviation 2.0673	-1.907 Millimoles per liter (mmol/L) Standard Deviation 2.9601

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24 (LOCF)

Population: FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (LOCF).

Outcome measures

Outcome measures
Measure	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of HbA1c Responders and Non-responders Responders	29 participants	33 participants
Number of HbA1c Responders and Non-responders Non-responders	9 participants	2 participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24 (LOCF)

Population: FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level \< 6.1 mmol/L at Week 24 (LOCF).

Outcome measures

Outcome measures
Measure	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of FPG Responders and Non-responders Non-responders	26 participants	14 participants
Number of FPG Responders and Non-responders Responders	12 participants	21 participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24 (LOCF)

Population: FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for HbA1c assessment.

Outcome measures

Outcome measures
Measure	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline HbA1c <7%	13 participants	13 participants
Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline HbA1c <=6.5%	8 participants	5 participants
Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline HbA1c decrease of >=0.7% from Baseline	29 participants	33 participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0).

Outcome measures

Outcome measures
Measure	Glimepiride n=34 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=32 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) Proinsulin; n=32, 34	3.1 Picomoles per liter (pmol/L) Standard Deviation 10.70	-2.9 Picomoles per liter (pmol/L) Standard Deviation 10.18
Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) Insulin; n=15, 19	24.9 Picomoles per liter (pmol/L) Standard Deviation 40.03	9.3 Picomoles per liter (pmol/L) Standard Deviation 32.27

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI\[milliunits (mU)/milliliter (ml)\]\*FG \[millimoles per liter (mmol/l)\])/22.5. numerator, num.; denominator, denom.

Outcome measures

Outcome measures
Measure	Glimepiride n=19 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=15 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW	-2.9173 Ratio: FI*FG (num.); 22.5 (denom.) Standard Deviation 4.5282	1.7248 Ratio: FI*FG (num.); 22.5 (denom.) Standard Deviation 7.2543

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20\*FI\[mU/ml\])/(FG\[mmol/l\]-3.5).

Outcome measures

Outcome measures
Measure	Glimepiride n=19 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=15 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW	1.0108 Ratio: 20*FI (num.); FG-3.5 (denom.) Standard Deviation 1.1724	1.0494 Ratio: 20*FI (num.); FG-3.5 (denom.) Standard Deviation 1.3229

SECONDARY outcome

Timeframe: Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm.

The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg.

Outcome measures

Outcome measures
Measure	Glimepiride n=38 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of Participants at Various Dose Levels at Week 24/EW Dose Level 1	7 participants	16 participants
Number of Participants at Various Dose Levels at Week 24/EW Dose Level 2	18 participants	8 participants
Number of Participants at Various Dose Levels at Week 24/EW Dose Level 3	13 participants	10 participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=37 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW TC; n=35, 36	0.186 mmol/L Standard Deviation 0.8849	0.146 mmol/L Standard Deviation 0.6736
Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW HDL-C; n=35, 34	0.091 mmol/L Standard Deviation 0.1797	-0.003 mmol/L Standard Deviation 0.2141
Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW LDL-C; n=34, 31	0.067 mmol/L Standard Deviation 0.6075	0.002 mmol/L Standard Deviation 0.5598
Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW TG; n=35, 37	0.056 mmol/L Standard Deviation 1.5312	0.344 mmol/L Standard Deviation 1.0933

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population: all participants who received at least one dose of study medication. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for BUN and electrolyte (sodium, potassium, chloride, calcium, and phosphorus) assessment. The electrolyte balance asseses the condition of the heart and the kidneys, and BUN assesses the condition of the kidneys. Change from Baseline in BUN, sodium, potassium, chloride, calcium, and phosphorus was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=39 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW BUN; n=39, 42	0.146 mmol/L Standard Deviation 1.3378	0.076 mmol/L Standard Deviation 0.8661
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW Sodium; n=39, 41	0.33 mmol/L Standard Deviation 2.749	-0.56 mmol/L Standard Deviation 2.926
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW Potassium; n=39, 41	0.086 mmol/L Standard Deviation 0.473	0.006 mmol/L Standard Deviation 0.4169
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW Chloride; n=39, 41	1.24 mmol/L Standard Deviation 3.295	-1.93 mmol/L Standard Deviation 17.653
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW Calcium; n=38, 35	0.037 mmol/L Standard Deviation 0.1122	0.035 mmol/L Standard Deviation 0.1481
Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW Phosphorus; n=36, 35	0.028 mmol/L Standard Deviation 0.1980	0.046 mmol/L Standard Deviation 0.1315

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C and LDL-C) assessment. The ratio of TC/HDL-C and LDL-C/HDL-C was calculated. Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C was calculated as the value at Week 24/EW minus the value at Baseline. For TC/HDL-C, the numerator is TC, and the denominator is HDL-C. For LDL-C/HDL-C, the numerator is LDL-C, and the denominator is HDL-C.

Outcome measures

Outcome measures
Measure	Glimepiride n=33 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW TC/HDL-C; n=35, 33	-0.1283 ratio Standard Deviation 0.9562	0.2295 ratio Standard Deviation 1.1037
Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW LDL-C/HDL-C; n=34, 31	-0.0782 ratio Standard Deviation 0.6222	0.0753 ratio Standard Deviation 0.8888

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Change from Baseline in hs-CRP was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=37 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW	2.74 mmol/L Standard Deviation 29.892	-10.71 mmol/L Standard Deviation 41.368

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Percent change from Baseline in hs-CRP was calculated as the value at Visit 8 (Wk 24)/ EW minus the value at Baseline divided by value at Wk 24/ EW multiplied by 100.

Outcome measures

Outcome measures
Measure	Glimepiride n=37 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW	0.00 percent change Interval -80.0 to 1320.2	-39.58 percent change Interval -94.8 to 2677.1

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

EQ-5D is used as a measure of health outcome and includes single-item measures (coded on a 3-point scale \[1, no problems; 2, some problems; 3, severe problems\]) of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument includes a global rating of current health using a visual analog scale (VAS): 0 (worst imaginable) to 100 (best imaginable). Health states may be converted to a single summary index by applying a formula that attaches values to each of the levels in each dimension. The index scale is -0.111 to 1. A lower index indicates worse health.

Outcome measures

Outcome measures
Measure	Glimepiride n=18 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=20 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW	0.0447 scores on a scale Standard Deviation 0.1504	0.0584 scores on a scale Standard Deviation 0.1903

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: FAS. Only those participants contributing data at the indicated time points were analyzed.

In diabetic participants, QOL, anxiety, and depression were measured by the A-DQOL scale . There are 46 core items (10 additional items for adolescents) and 4 major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Participants respond to all items on a 5-point Likert scale: 1, no impact, no worries, or always satisfied; 5, always affected, always worried, or never satisfied. The total score is a sum of the individual scores of all 46 items (range of 46 to 230); a lower score indicates a better QOL.

Outcome measures

Outcome measures
Measure	Glimepiride n=16 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=17 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW	-0.1 scores on a scale Standard Deviation 18.63	-7.0 scores on a scale Standard Deviation 11.10

SECONDARY outcome

Timeframe: Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for the assessment of blood glucose levels. Hypoglycemia is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants; participants with HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG \<6.1 mmol/L at Week 24 (FPG responders) were evaluated.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=40 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of Participants With Hypoglycemic Events All participants with any hypoglycemic events (HE)	7 participants	8 participants
Number of Participants With Hypoglycemic Events HbA1c responders with any HEs	6 participants	7 participants
Number of Participants With Hypoglycemic Events FPG responders with any HEs	0 participants	5 participants

SECONDARY outcome

Timeframe: Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

A hypoglycemic event is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants, participants with HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG \<6.1 mmol/L at Week 24 (FPG responders) were evaluated.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=40 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of Hypoglycemic Events HE for all participants	11 Hypoglycemic events	13 Hypoglycemic events
Number of Hypoglycemic Events HE for HbA1c responders	10 Hypoglycemic events	12 Hypoglycemic events
Number of Hypoglycemic Events HE for FPG responders	0 Hypoglycemic events	9 Hypoglycemic events

SECONDARY outcome

Timeframe: Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Participants with a break in the continuity (fracture) of the bone were evaluated.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=40 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Number of Participants With a Bone Fracture	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for WBC count and platelet count assessment. Change from Baseline in WBC count and platelet count was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=38 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW WBC count	0.148 Giga per liter (10^9/L) cells Standard Deviation 0.8855	-0.418 Giga per liter (10^9/L) cells Standard Deviation 0.9091
Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW Platelet count	3.4 Giga per liter (10^9/L) cells Standard Deviation 34.17	-5.7 Giga per liter (10^9/L) cells Standard Deviation 33.73

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for RBC count assessment. Change from Baseline in RBC count was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=38 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Red Blood Cell (RBC) Count at Week 24/EW	-0.003 Pico per liter (10^12/ L) cells Standard Deviation 0.2288	-0.213 Pico per liter (10^12/ L) cells Standard Deviation 0.2577

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for lymphocyte, monocyte, neutrophil, eosinophil, and basophil assessment. Change from Baseline in lymphocytes, monocytes, neutrophils, eosinophils, and basophils was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=38 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW Lymphocytes; n=38, 42	-2.33 percent of WBC count Standard Deviation 5.718	1.53 percent of WBC count Standard Deviation 5.454
Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW Monocytes; n=38, 42	-0.33 percent of WBC count Standard Deviation 1.165	0.47 percent of WBC count Standard Deviation 1.345
Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW Neutrophils; n=38, 42	2.73 percent of WBC count Standard Deviation 6.065	-2.84 percent of WBC count Standard Deviation 6.059
Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW Eosinophils; n=35, 42	-0.12 percent of WBC count Standard Deviation 1.116	0.61 percent of WBC count Standard Deviation 1.271
Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW Basophils; n=35, 42	0.05 percent of WBC count Standard Deviation 0.473	0.09 percent of WBC count Standard Deviation 0.255

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for HCT assessment. Change from Baseline in HCT was calculated as the value at Week 24/EW minus the value at Baseline. HCT is measured as the percentage of the volume of whole blood that is made up of red blood cells.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Hematocrit (HCT) at Week 24/EW	0.52 percentage of volume of whole blood Standard Deviation 2.076	-1.21 percentage of volume of whole blood Standard Deviation 1.951

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for HE, MCHC, and TP assessment. Change from Baseline in HE, MCHC, and TP was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=39 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW HE; n=38, 42	1.5 Grams per liter (G/L) Standard Deviation 6.15	-3.7 Grams per liter (G/L) Standard Deviation 5.81
Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW MCHC; n=35, 42	-0.9 Grams per liter (G/L) Standard Deviation 11.28	-0.2 Grams per liter (G/L) Standard Deviation 10.05
Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW TP; n=39, 42	1.45 Grams per liter (G/L) Standard Deviation 4.416	-1.12 Grams per liter (G/L) Standard Deviation 3.386
Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW Albumin; n=39, 42	1.44 Grams per liter (G/L) Standard Deviation 3.282	-0.21 Grams per liter (G/L) Standard Deviation 2.323

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for MCV assessment. Change from Baseline in MCV was calculated as the value at Week 24/EW minus the value at Baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the RBC count in millions per microliter of blood, then multiplying by 10. MCV is one of the three main RBC indices that are helpful in determining the cause of anemia.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Mean Corpuscular Volume (MCV) at Week 24/EW	1.01 Femtoliters (FL) per cell Standard Deviation 1.934	1.82 Femtoliters (FL) per cell Standard Deviation 2.698

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for MCH assessment. Change from Baseline in MCH was calculated as the value at Week 24/EW minus the value at Baseline. MCH is the average amount of hemoblobin inside a RBC expressed in picograms. MCH is calculated by dividing the hemoglobin concentration in grams per deciliter by the RBC count in millions per microliter, then multiplying by 10. MCH is one of the three main RBC indices which are helpful to determine the cause of anemia.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=35 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Week 24/EW	0.28 Picograms (pg) per cell Standard Deviation 0.820	0.60 Picograms (pg) per cell Standard Deviation 1.040

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for ALT, AST, GGT, LDH, ALP, and CK assessment. Change from Baseline in ALT, AST, GGT, LDH, ALP, and CK was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=39 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW ALT; n=39, 42	-4.30 Units per liter (U/L) Standard Deviation 12.592	-6.23 Units per liter (U/L) Standard Deviation 16.281
Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW AST; n=38, 38	-4.2 Units per liter (U/L) Standard Deviation 8.67	-3.5 Units per liter (U/L) Standard Deviation 11.95
Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW GGT; n=37, 36	-1.5 Units per liter (U/L) Standard Deviation 13.53	-30.0 Units per liter (U/L) Standard Deviation 90.40
Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW LDH; n=38, 37	1.6 Units per liter (U/L) Standard Deviation 23.81	2.0 Units per liter (U/L) Standard Deviation 37.22
Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW ALP; n=38, 38	-2.8 Units per liter (U/L) Standard Deviation 15.21	-13.3 Units per liter (U/L) Standard Deviation 13.18
Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW CK; n=35, 41	-1.8 Units per liter (U/L) Standard Deviation 28.01	20.8 Units per liter (U/L) Standard Deviation 35.85

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood samples of participants were collected for TB, DB, creatinine, and UC assessment. Change from Baseline in TB, DB, creatinine, and UC was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=42 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=39 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW TB; n=39, 41	-3.44 Micromoles per liter (mcmol/L) Standard Deviation 4.416	-5.33 Micromoles per liter (mcmol/L) Standard Deviation 5.363
Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW DB; n=39, 42	-0.63 Micromoles per liter (mcmol/L) Standard Deviation 1.454	-1.20 Micromoles per liter (mcmol/L) Standard Deviation 1.923
Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW Creatitine; n=39, 42	-1.14 Micromoles per liter (mcmol/L) Standard Deviation 8.239	1.03 Micromoles per liter (mcmol/L) Standard Deviation 6.579
Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW UC; n=39, 42	4.96 Micromoles per liter (mcmol/L) Standard Deviation 60.360	-13.58 Micromoles per liter (mcmol/L) Standard Deviation 58.919

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

The blood pressure of the participants was measured. Change from Baseline in SBP and DBP was calculated as the value at Weeks 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=40 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW SBP	3.1 Millimeters of mercury (mmHg) Standard Deviation 11.14	2.0 Millimeters of mercury (mmHg) Standard Deviation 15.73
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW DBP	2.1 Millimeters of mercury (mmHg) Standard Deviation 9.73	2.2 Millimeters of mercury (mmHg) Standard Deviation 10.07

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

The heart rate of the participants was measured. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=40 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Heart Rate at Week 24/EW	-0.4 beats per minute (bpm) Standard Deviation 6.96	1.1 beats per minute (bpm) Standard Deviation 9.20

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

The weight of the participants was measured. Change from Baseline in weight was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=40 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Weight at Week 24/EW	1.43 kilograms (kg) Standard Deviation 1.867	1.55 kilograms (kg) Standard Deviation 2.632

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Electrocardiograms of the participants were taken for the evaluation of heart rate. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=38 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Electrocardiogram (ECG) Assessment of Heart Rate at Week 24/EW	3.0 bpm Standard Deviation 6.74	-1.5 bpm Standard Deviation 7.65

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 24/EW

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

PR, QT, QTc, RR, QRS, and QRS axis data were measured by ECG. The PR interval (int.) starts at the beginning of the atrial contraction and ends at the beginning of the ventricular contraction. QT (QT int.) and QTc (corrected QT int.) indicate how fast the ventricles are repolarized, becoming ready for a new cycle. The RR int. represents the duration of the ventricular cardiac cycle and is an indicator of ventricular rate. QRS (QRS duration) indicates how fast the ventricles depolarize. The QRS axis is an indicator of the electrical heart axis, which is an average of all heart depolarization.

Outcome measures

Outcome measures
Measure	Glimepiride n=43 Participants Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Rosiglitazone+Glimepiride FDC n=38 Participants Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW PR intervals; n=38, 43	-5.6 milliseconds (msec) Standard Deviation 13.93	1.5 milliseconds (msec) Standard Deviation 9.92
Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW QT intervals; n=38, 43	-9.0 milliseconds (msec) Standard Deviation 31.18	3.6 milliseconds (msec) Standard Deviation 18.34
Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW QTc intervals; n=37, 43	-3.1 milliseconds (msec) Standard Deviation 38.14	-0.9 milliseconds (msec) Standard Deviation 14.01
Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW RR intervals; n=37, 43	-33.4 milliseconds (msec) Standard Deviation 98.12	16.1 milliseconds (msec) Standard Deviation 80.24
Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW QRS intervals; n=37, 43	-1.0 milliseconds (msec) Standard Deviation 10.36	-0.5 milliseconds (msec) Standard Deviation 7.52
Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW QRS axis intervals; n=37, 43	0.5 milliseconds (msec) Standard Deviation 16.88	1.8 milliseconds (msec) Standard Deviation 13.17

Adverse Events

Rosiglitazone+Glimepiride FDC

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Glimepiride

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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 centers of a multi-center 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

Measure	Rosiglitazone+Glimepiride FDC n=40 participants at risk Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (\>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).	Glimepiride n=43 participants at risk Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG \>=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
General disorders Fatigue	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Blood and lymphatic system disorders Hyperbilirubinemia	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Cardiac disorders Bundle branch block left	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Investigations Blood creatine phosphokinase increased	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	0.00% 0/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Renal and urinary disorders Proteinuria	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	0.00% 0/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hyperlipidemia	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Gastroenteritis	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	0.00% 0/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Nausea	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	0.00% 0/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Vascular disorders Hypertension	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	4.7% 2/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
Vascular disorders Dizziness	0.00% 0/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	2.3% 1/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
General disorders Chest discomfort	2.5% 1/40 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.	0.00% 0/43 Serious adverse events and non-serious adverse events were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.