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

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.

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).

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).

Blood samples of participants were collected for HbA1c assessment.

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).

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.