| Outcome Measures: |
Primary: Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy, 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., Baseline (Week 0) and Week 6 | Secondary: Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy, 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., Baseline (Week 0) and Week 16|Median Percent Change From Baseline to Week 6 in LDL-c, 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., Baseline (Week 0) and Week 6|Mean Change From Baseline to Week 16 in HbA1c, 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., Baseline (Week 0) and Week 16|Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG), 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., Baseline (Week 0) and Week 16|Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6, 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., Week 6|Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16, 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., Up to Week 16|Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16, 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., Week 16|On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate, 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., Up to Week 16|On-Therapy Change From Baseline in Body Weight, 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., Up to Week 16|Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine, 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., Up to Week 16|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE), 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., Up to Week 16|Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline, 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., Up to Week 16
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| Locations: |
GSK Investigational Site, Tucson, Arizona, 85745, United States|GSK Investigational Site, Fresno, California, 93720, United States|GSK Investigational Site, Wheat Ridge, Colorado, 80033, United States|GSK Investigational Site, Waterbury, Connecticut, 06708, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Saint Cloud, Florida, 34769, United States|GSK Investigational Site, Atlanta, Georgia, 30308, United States|GSK Investigational Site, Chicago, Illinois, 60607, United States|GSK Investigational Site, Melrose Park, Illinois, 60160, United States|GSK Investigational Site, Springfield, Illinois, 62704, United States|GSK Investigational Site, Avon, Indiana, 46123, United States|GSK Investigational Site, Elkhart, Indiana, 46515, United States|GSK Investigational Site, Sunset, Louisiana, 70584, United States|GSK Investigational Site, Waltham, Massachusetts, 02453, United States|GSK Investigational Site, Saint Peters, Missouri, 63376, United States|GSK Investigational Site, Billings, Montana, 59102, United States|GSK Investigational Site, Las Vegas, Nevada, 89103, United States|GSK Investigational Site, Jamaica, New York, 11432, United States|GSK Investigational Site, Rochester, New York, 14609, United States|GSK Investigational Site, Columbus, Ohio, 43212, United States|GSK Investigational Site, Bend, Oregon, 97701, United States|GSK Investigational Site, Portland, Oregon, 97216, United States|GSK Investigational Site, Portland, Oregon, 97219, United States|GSK Investigational Site, Portland, Oregon, 97239, United States|GSK Investigational Site, Tualatin, Oregon, 97062, United States|GSK Investigational Site, Beaver, Pennsylvania, 15009, United States|GSK Investigational Site, Fleetwood, Pennsylvania, 19522, United States|GSK Investigational Site, Jefferson Hills, Pennsylvania, 15025, United States|GSK Investigational Site, Philadelphia, Pennsylvania, 19152, United States|GSK Investigational Site, Clinton, South Carolina, 29325, United States|GSK Investigational Site, Columbia, South Carolina, 29201, United States|GSK Investigational Site, Kingsport, Tennessee, 37660, United States|GSK Investigational Site, Bryan, Texas, 77802, United States|GSK Investigational Site, Dallas, Texas, 75230, United States|GSK Investigational Site, Georgetown, Texas, 78626, United States|GSK Investigational Site, Midland, Texas, 79705, United States|GSK Investigational Site, Plano, Texas, 75093, United States|GSK Investigational Site, Salt Lake City, Utah, 84143, United States|GSK Investigational Site, Burke, Virginia, 22015, United States|GSK Investigational Site, Manassas, Virginia, 20110, United States|GSK Investigational Site, Bellevue, Washington, 98004, United States|GSK Investigational Site, Spokane, Washington, 99208, United States|GSK Investigational Site, Vancouver, Washington, 98664, United States|GSK Investigational Site, Wollongong, New South Wales, 2500, Australia|GSK Investigational Site, Kippa Ring, Queensland, 4021, Australia|GSK Investigational Site, Adelaide, South Australia, 5000, Australia|GSK Investigational Site, Keswick, South Australia, 5035, Australia|GSK Investigational Site, Port Lincoln, South Australia, 5606, Australia|GSK Investigational Site, Box Hill, Victoria, 3128, Australia|GSK Investigational Site, Heidelberg West, Victoria, 3081, Australia|GSK Investigational Site, Ringwood East, Victoria, 3135, Australia|GSK Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|GSK Investigational Site, Edmonton, Alberta, T5N 3Y6, Canada|GSK Investigational Site, Coquitlam, British Columbia, V3K 3V9, Canada|GSK Investigational Site, Moncton, New Brunswick, E1G1A7, Canada|GSK Investigational Site, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|GSK Investigational Site, Halifax, Nova Scotia, B3K 5R3, Canada|GSK Investigational Site, Truro, Nova Scotia, B2N 1L2, Canada|GSK Investigational Site, Brampton, Ontario, L6T 3T1, Canada|GSK Investigational Site, Hamilton, Ontario, L8M 1K7, Canada|GSK Investigational Site, North Bay, Ontario, P1B 2H3, Canada|GSK Investigational Site, Sudbury, Ontario, P3A 1Y8, Canada|GSK Investigational Site, Toronto, Ontario, M3H 5S4, Canada|GSK Investigational Site, Toronto, Ontario, M8V 3X8, Canada|GSK Investigational Site, Toronto, Ontario, M9W 4L6, Canada|GSK Investigational Site, Woodstock, Ontario, N4S 4G3, Canada|GSK Investigational Site, Bonaventure, Quebec, G0C 1E0, Canada|GSK Investigational Site, Gatineau, Quebec, J8Y 6S8, Canada|GSK Investigational Site, Granby, Quebec, J2G 8Z9, Canada|GSK Investigational Site, Montreal, Quebec, H2K 4L5, Canada|GSK Investigational Site, Plessisville, Quebec, G6L 3J1, Canada|GSK Investigational Site, Pointe-Claire, Quebec, H9R 4S3, Canada|GSK Investigational Site, Saint Marc Des Carrieres, Quebec, G0A 4B0, Canada|GSK Investigational Site, Sainte-Foy, Quebec, G1V 1V6, Canada|GSK Investigational Site, Sainte-Foy, Quebec, G1V 4G2, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 4J6, Canada|GSK Investigational Site, Saskatoon, Saskatchewan, S7K 7H9, Canada|GSK Investigational Site, Guadalajara, Jalisco, 44340, Mexico|GSK Investigational Site, Cuernavaca, Morelos, 62420, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64570, Mexico|GSK Investigational Site, Mexico, 14080, Mexico|GSK Investigational Site, Manila, 1008, Philippines|GSK Investigational Site, Quezon City, 1100, Philippines|GSK Investigational Site, Quezon City, 1113, Philippines|GSK Investigational Site, Carolina, 00983, Puerto Rico
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