| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | 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. | 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. | Posted | | Mean | Standard Deviation | Percent of total hemoglobin | | Baseline (Week 0) and Week 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.75± 1.078
- OG001-1.47± 1.227
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | 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. | 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. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | Baseline (Week 0) and Week 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Number of HbA1c Responders and Non-responders | 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). | 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. | Posted | | Number | | participants | | Baseline (Week 0) and Week 24 (LOCF) | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Number of FPG Responders and Non-responders | 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). | 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. | Posted | | Number | | participants | | Baseline (Week 0) and Week 24 (LOCF) | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline | Blood samples of participants were collected for HbA1c assessment. | 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. | Posted | | Number | | participants | | Baseline (Week 0) and Week 24 (LOCF) | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) | 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). | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Picomoles per liter (pmol/L) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride |
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| Secondary | Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Ratio: FI*FG (num.); 22.5 (denom.) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride |
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| Secondary | Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW | 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). | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Ratio: 20*FI (num.); FG-3.5 (denom.) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride | |
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| Secondary | Number of Participants at Various Dose Levels at Week 24/EW | 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. | 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. | Posted | | Number | | participants | | Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | 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 | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW | 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. | 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. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride | |
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| Secondary | Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | ratio | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Median | Full Range | percent change | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride |
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| Secondary | Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW | 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. | FAS. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride |
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| Secondary | Number of Participants With Hypoglycemic Events | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Number | | participants | | Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Number of Hypoglycemic Events | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Number | | Hypoglycemic events | | Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Number of Participants With a Bone Fracture | Participants with a break in the continuity (fracture) of the bone were evaluated. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Number | | participants | | Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Giga per liter (10^9/L) cells | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Red Blood Cell (RBC) Count at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Pico per liter (10^12/ L) cells | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | percent of WBC count | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Hematocrit (HCT) at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | percentage of volume of whole blood | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter (G/L) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Mean Corpuscular Volume (MCV) at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Femtoliters (FL) per cell | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Picograms (pg) per cell | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | 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 | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Micromoles per liter (mcmol/L) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Heart Rate at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Weight at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | kilograms (kg) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Electrocardiogram (ECG) Assessment of Heart Rate at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | bpm | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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). |
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| Secondary | Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW | 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. | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | milliseconds (msec) | | Baseline (Week 0) and Week 24/EW | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Glimepiride |
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