Trial Outcomes & Findings for A Study In Patients With Type 2 Diabetes Mellitus (NCT NCT00256867)

The study was conducted between 17 April 2005 and 21 December 2006 at 68 centers in five countries including United States, Canada, Australia, Mexico, and the Philippines. A total of 370 participants were randomized of which 1 participant did not received study medication remaining 369 participants were included in safety population.

Out of the 369 participants from safety population, 12 participants received at least one dose but did not have at least one On-Therapy value for any efficacy assessment, the remaining 357 participants were included in Intent- to-Treat population.

A Study In Patients With Type 2 Diabetes Mellitus

Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.

Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.

Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.

Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.

Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.

Number of participants achieving American Diabetes Association (ADA) target of LDL\<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.

Number of participants achieving ADA target of HbA1c \< 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.

Number of participants achieving ADA target of FPG\< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.

The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (\<85 and \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (\<45 and \>100 mmHg) and heart rate (\<40 and \>110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.

Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value.

Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.

AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.