| Outcome Measures: |
Primary: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE), An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury., Up to Week 12|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12., Baseline (pre-dose Day 1) and up to Week 12|Change From Baseline in Heart Rate, Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12., Baseline (pre-dose Day 1) and up to Week 12|Number of Participants With Abnormal Electrocardiograms (ECGs) Findings, Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented., Up to Week 20|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI), Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided., Up to Week 12|Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI), Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided., Up to Week 12|Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick, Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL)., Up to Week 12|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12, Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12., Baseline (Day -1) and up to Week 12 | Secondary: Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6, Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6., Baseline (Day 1) and up to Week 6|GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship, The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected., Up to Week 12|Change From Baseline in Fasting Plasma Glucose at Week 12, Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12., Baseline (Day 1) and up to Week 12|Change From Baseline in Fasting Insulin at Week 12, Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12., Baseline (Day 1) and up to Week 12|Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12, Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12., Baseline (Day 1) and up to Week 12|Change From Baseline in Fructosamine at Week 6 and Week 12, Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12., Baseline (Day -1) and Week 12|Number of Participants With HbA1c < 7.0% and < 6.5%, Data has been presented for number of participants with their corresponding percentages with HbA1c \<7.0% and \<6.5%., Up to Week 12
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| Locations: |
GSK Investigational Site, Anniston, Alabama, 36207, United States|GSK Investigational Site, Miami, Florida, 33169, United States|GSK Investigational Site, Miramar, Florida, 33025, United States|GSK Investigational Site, Nantes cedex 01, 44093, France|GSK Investigational Site, Pierre-Bénite Cedex, 69495, France|GSK Investigational Site, Rennes Cedex, 35046, France|GSK Investigational Site, Rueil-Malmaison, 92502, France|GSK Investigational Site, Alicante, 03114, Spain|GSK Investigational Site, Badalona, 08916, Spain|GSK Investigational Site, Granada, 18004, Spain|GSK Investigational Site, Madrid, 28046, Spain|GSK Investigational Site, Edinburgh, Midlothian, EH4 2XU, United Kingdom|GSK Investigational Site, Cambridge, CB2 0GG, United Kingdom|GSK Investigational Site, Coventry, CV2 2DX, United Kingdom|GSK Investigational Site, Newcastle upon Tyne, NE1 4LP, United Kingdom
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