| Outcome Measures: |
Primary: Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control, Improvement in glucose control was measured by means of reduction in glycated hemoglobin (Hb) levels in blood., Week (W) 16 | Secondary: Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12, Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. Change from Baseline is the value at indicated time point minus the value at Baseline., Weeks 4, 8, and 12|Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16, Change from Baseline is the value at indicated time point minus the value at Baseline., W1, W2, W4, W6, W8, W12, and W16|Change from Baseline (Day 1) in fasting fructosamine at Weeks 2 and 4, Change from Baseline is the value at indicated time point minus the value at Baseline., Baseline (Day 1), W2, W4|Percentage of participants achieving target HbA1c levels at Weeks 4, 8, 12, and 16, Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. The ideal concentration of HbA1c was desired to be less than or equal to 7%., Weeks 4, 8, 12, and 16|Percentage of participants achieving a decrease in HbA1c of >= 0.7% from Baseline (Day 1) at Weeks 4, 8, 12 and 16, Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood., Baseline (Day 1), Weeks 4, 8, 12, and 16|Percentage of participants achieving target range of FPG at Weeks 1, 2, 4, 6, 8, 12 and 16, The target range for FPG was \<=126 milligrams per deciliter (mg/dL) or 7.0 millimoles per liter (mmol/L) to \<=140 mg/dL or 7.8 mmol/L, Weeks 1,2, 4, 6, 8, 12, and 16|Percentage of participants achieving a decrease from Baseline (Day 1) of >=30 mg/dL [1.66 mmol/L] in FPG at Weeks 1, 2, 4, 6, 8, 12 and 16, Change from Baseline is the value at indicated time point minus the value at Baseline., Weeks 1, 2, 4, 6, 8, 12, and 16|Ratio to the Baseline (percentage change) of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and free fatty acids (FFA) at Weeks 2, 4, 8, 12, and 16, This data analysis was based on log-transformed data., Baseline (Day 1), Weeks 2, 4, 8, 12, and 16|Percentage change from Baseline (Day 1) in non-HDL-C based on log-transformed data at Week 16, Change from Baseline is the value at indicated time point minus the value at Baseline., At Week 16|Percentage change from Baseline (Day 1) in very low density lipoprotein-cholesterol (VLDL-C), apolipoprotein AI (Apo AI), AII, and B at Week 16., Change from Baseline is the value at indicated time point minus the value at Baseline., At Week 16|Change from Baseline (Day 1) in Apo B/TC, TC/HDL-C, and LDL-C/Apo B ratio at Week 16, Change from Baseline is the value at indicated time point minus the value at Baseline., At Week 16|Change from Baseline (Day 1) in hemoglobin at Week 16, This analysis was performed in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline., At Week 16|Change from Baseline (Day 1) in hematocrit at Week 16, Change from Baseline is the value at indicated time point minus the value at Baseline., Wekk 16|Change from Baseline (Day 1) in systolic and diastolic blood pressure (SBP and DBP) at Week 16, Systolic blood pressure )SBP) and diastolic blood pressure (DBP) were measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline., At Week 16|Change from Baseline (Day 1) in heart rate at Week 16, Heart rate was measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline., Week 16|Change from Baseline (Day 1) in body weight at Week 16, Change from Baseline is the value at indicated time point minus the value at Baseline., Week 16|Change from Baseline (Day 1) in 12 lead electrocardiogram (ECG) measures including PR interval, QT interval, QTc interval and QRS duration at Week 16, QT(c) interval calculations were done by Bazett's method (QTc\[B\]) as well as by Fridericia's correction (QTc\[F\]). Change from Baseline is the value at indicated time point minus the Baseline value., Week 16|Number of participants with clinical hematology, chemistry, urinalysis, exploratory cardiac parameters of potential clinical concern (PCC) along with serum pregnancy test over period, Participants were analyzed for any abnormality for laboratory parameters either higher or lower than the potential clinical concern range., Upto 16 weeks|Number of participants with hypoglycemic events as a measure of ophthalmic assessment, Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis., Up to 16 weeks|Number of participants with intensity of hypoglycemic events as a measure of ophthalmic assessment, Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis., Up to 16 weeks|Number of participants with adverse events (AEs) and serious adverse events (SAEs) over period, Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above., Up to 16 weeks|Change from Baseline (Day 1) in phosphocreatine kinase (Creatine kinase-MB) over period, CK-MB is a cardiac biomarker., Up to 16 weeks|Number of participants with absolute Troponin-I (cTnI) levels over period, Troponin-I (cTnI) is a cardiac biomarker., Up to 16 weeks|Change from Baseline (Day 1) in fasting insulin at Week 8 and 16, Change from Baseline is the value at indicated time point minus the value at Baseline., Week 8 and 16|Change from Baseline (Day 1) in C-peptide at Week 8 and 16, Week 8 and 16|Change from Baseline (Day 1) in HOMA-S at Week 16, Week 16|Change from Baseline (Day 1) in QUICKI at Week 16, Week 16
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| Locations: |
GSK Investigational Site, Birmingham, Alabama, 35205, United States|GSK Investigational Site, Northport, Alabama, 35476, United States|GSK Investigational Site, Chandler, Arizona, 85224, United States|GSK Investigational Site, Phoenix, Arizona, 85006, United States|GSK Investigational Site, Phoenix, Arizona, 85032, United States|GSK Investigational Site, Alhambra, California, 91801, United States|GSK Investigational Site, Artesia, California, 90701, United States|GSK Investigational Site, Huntington Beach, California, 92648, United States|GSK Investigational Site, Inglewood, California, 90301, United States|GSK Investigational Site, Irvine, California, 92618, United States|GSK Investigational Site, LaJolla, California, 92037, United States|GSK Investigational Site, Long Beach, California, 90806, United States|GSK Investigational Site, Los Angeles, California, 90057, United States|GSK Investigational Site, Los Angeles, California, 90095, United States|GSK Investigational Site, Northridge, California, 91325, United States|GSK Investigational Site, Norwalk, California, 90650, United States|GSK Investigational Site, Pasadena, California, 91105, United States|GSK Investigational Site, Sacramento, California, 95825, United States|GSK Investigational Site, San Diego, California, 92128, United States|GSK Investigational Site, San Diego, California, 92177, United States|GSK Investigational Site, Santa Monica, California, 90404, United States|GSK Investigational Site, Tustin, California, 92780, United States|GSK Investigational Site, Vista, California, 92084, United States|GSK Investigational Site, West Hills, California, 91307, United States|GSK Investigational Site, Denver, Colorado, 80220, United States|GSK Investigational Site, Norwich, Connecticut, 06360, United States|GSK Investigational Site, Hollywood, Florida, 33021, United States|GSK Investigational Site, Hollywood, Florida, 33023, United States|GSK Investigational Site, Largo, Florida, 33773, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Sarasota, Florida, 34239, United States|GSK Investigational Site, St. Cloud, Florida, 34769, United States|GSK Investigational Site, Atlanta, Georgia, 30342, United States|GSK Investigational Site, Duluth, Georgia, 30097, United States|GSK Investigational Site, Honolulu, Hawaii, 96813, United States|GSK Investigational Site, Springfield, Illinois, 62701, United States|GSK Investigational Site, Indianapolis, Indiana, 46260, United States|GSK Investigational Site, West Yarmouth, Massachusetts, 02673, United States|GSK Investigational Site, St. Louis, Missouri, 63110, United States|GSK Investigational Site, St. Louis, Missouri, 63141, United States|GSK Investigational Site, Henderson, Nevada, 89014, United States|GSK Investigational Site, Henderson, Nevada, 89015, United States|GSK Investigational Site, Las Vegas, Nevada, 89106, United States|GSK Investigational Site, Las Vegas, Nevada, 89119, United States|GSK Investigational Site, Las Vegas, Nevada, 89128, United States|GSK Investigational Site, Pahrump, Nevada, 89048, United States|GSK Investigational Site, Albuquerque, New Mexico, 87102, United States|GSK Investigational Site, Santa Fe, New Mexico, 87505, United States|GSK Investigational Site, New York, New York, 10024, United States|GSK Investigational Site, New York, New York, 10032, United States|GSK Investigational Site, Greensboro, North Carolina, 27401, United States|GSK Investigational Site, Cleveland, Ohio, 44195, United States|GSK Investigational Site, Franklin, Ohio, 45005, United States|GSK Investigational Site, Philadelphia, Pennsylvania, 19107, United States|GSK Investigational Site, East Providence, Rhode Island, 02914, United States|GSK Investigational Site, Greer, South Carolina, 29651, United States|GSK Investigational Site, Simpsonville, South Carolina, 29681, United States|GSK Investigational Site, Cite, Tennessee, 37604, United States|GSK Investigational Site, Kingsport, Tennessee, 37660, United States|GSK Investigational Site, Dallas, Texas, 75246, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, Tyler, Texas, 75708, United States|GSK Investigational Site, Salt Lake City, Utah, 84109, United States|GSK Investigational Site, West Jordan, Utah, 84084, United States|GSK Investigational Site, Virginia Beach, Virginia, 23451, United States|GSK Investigational Site, Edmonds, Washington, 98026, United States|GSK Investigational Site, Everett, Washington, 98208, United States|GSK Investigational Site, Monroe, Washington, 98272, United States|GSK Investigational Site, Wauwatosa, Wisconsin, 53226, United States|GSK Investigational Site, Capital Federal, Buenos Aires, 1181, Argentina|GSK Investigational Site, Capital Federal, Buenos Aires, C1221ACI, Argentina|GSK Investigational Site, Cordoba, Córdova, 5000, Argentina|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, San Juan, 5400, Argentina|GSK Investigational Site, Miranda, New South Wales, 2228, Australia|GSK Investigational Site, Carina Heights, Queensland, 4152, Australia|GSK Investigational Site, Spring Hill, Queensland, 4000, 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, Ringwood East, Victoria, 3135, Australia|GSK Investigational Site, Langley, British Columbia, V3A 4H9, Canada|GSK Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|GSK Investigational Site, Saint John's, Newfoundland and Labrador, A1E 2C2, Canada|GSK Investigational Site, Halifax, Nova Scotia, B3K 5R3, Canada|GSK Investigational Site, Brampton, Ontario, L6T 3J1, Canada|GSK Investigational Site, London, Ontario, N5W 6A2, Canada|GSK Investigational Site, Mississauga, Ontario, L5A 1N1, Canada|GSK Investigational Site, Ottawa, Ontario, K1H 1A2, Canada|GSK Investigational Site, Smiths Falls, Ontario, K7A 4W8, Canada|GSK Investigational Site, Sudbury, Ontario, P3A 1Y8, Canada|GSK Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|GSK Investigational Site, Toronto, Ontario, M4R 2G4, Canada|GSK Investigational Site, Toronto, Ontario, M9W 4L6, Canada|GSK Investigational Site, Waterloo, Ontario, N2J 1C4, Canada|GSK Investigational Site, Bonaventure, Quebec, G0C 1E0, Canada|GSK Investigational Site, Granby, Quebec, J2G 8Z9, Canada|GSK Investigational Site, Laval, Quebec, H7T 2P5, Canada|GSK Investigational Site, Longueuil, Quebec, J4N 1L6, Canada|GSK Investigational Site, Montreal, Quebec, H4N 2W2, 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, Sainte-Foy, Quebec, G1V 4G5, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1G 5K2, Canada|GSK Investigational Site, Quebec, G1W 4R4, Canada|GSK Investigational Site, Bogotá, Colombia|GSK Investigational Site, San José, Costa Rica|GSK Investigational Site, Ceske Budejovice, 370 87, Czech Republic|GSK Investigational Site, Cheb, 350 02, Czech Republic|GSK Investigational Site, Olomouc, 779 00, Czech Republic|GSK Investigational Site, Praha 10, 10000, Czech Republic|GSK Investigational Site, Praha 2, 128 08, Czech Republic|GSK Investigational Site, Praha 5, 15030, Czech Republic|GSK Investigational Site, Praha 5, 158 00, Czech Republic|GSK Investigational Site, Quito, Ecuador|GSK Investigational Site, Cesis, LV4100, Latvia|GSK Investigational Site, Daugavpils, LV5417, Latvia|GSK Investigational Site, Riga, LV 1002, Latvia|GSK Investigational Site, Riga, LV1024, Latvia|GSK Investigational Site, Tukums, LV 3100, Latvia|GSK Investigational Site, Tijuana, Baja California Norte, 22320, Mexico|GSK Investigational Site, Pachuca, Hidalgo, 42039, Mexico|GSK Investigational Site, Cuernavaca, Morelos, 62420, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64570, Mexico|GSK Investigational Site, Durango, 3400, Mexico|GSK Investigational Site, Mexico, D.F., 11650, Mexico|GSK Investigational Site, Auckland, 1309, New Zealand|GSK Investigational Site, Auckland, 1311, New Zealand|GSK Investigational Site, Christchurch, 8001, New Zealand|GSK Investigational Site, Rotorua, 3201, New Zealand|GSK Investigational Site, Tauranga, 3001, New Zealand|GSK Investigational Site, San Isidro, Lima, Lima 27, Peru|GSK Investigational Site, Lima, Lima 14, Peru|GSK Investigational Site, Lima, Lima 1, Peru|GSK Investigational Site, Lima, Lima 27, Peru|GSK Investigational Site, Moscow, 117 036, Russian Federation|GSK Investigational Site, Perm, 614600, Russian Federation|GSK Investigational Site, Samara, 443067, Russian Federation|GSK Investigational Site, Tumen, 625023, Russian Federation|GSK Investigational Site, Ufa, 450000, Russian Federation|GSK Investigational Site, Yaroslavl, 150062, Russian Federation
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