| Outcome Measures: |
Primary: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE), An AE is defined as any untoward medical occurrence in a 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 may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included., From Baseline through Week 52|Number of Participants With Any Hypoglycemic Event, Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations., From Baseline through Week 52 | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis., Baseline and Week 52|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52), HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as \<6.5% and \<7.0%., Week 52|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52, FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis., Baseline and Week 52|Change From Baseline in Body Weight at Week 52, The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis., Baseline and Week 52|Time to Study Withdrawal Due to Hyperglycemia, Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose \>=280 mg/dL (\>=15.5 mmol/L) from \>=Week 2 to \<Week 12 or \>=230 mg/dL (\>=12.8 mmol/L) from \>=Week 12 to \<Week 52., Week 52
|
| Locations: |
GSK Investigational Site, Aichi, 456-0058, Japan|GSK Investigational Site, Chiba, 263-0043, Japan|GSK Investigational Site, Ehime, 792-8586, Japan|GSK Investigational Site, Fukuoka, 810-0014, Japan|GSK Investigational Site, Fukuoka, 815-8588, Japan|GSK Investigational Site, Fukuoka, 819-0168, Japan|GSK Investigational Site, Fukushima, 960-0418, Japan|GSK Investigational Site, Fukushima, 963-8851, Japan|GSK Investigational Site, Gunma, 370-3573, Japan|GSK Investigational Site, Gunma, 379-0116, Japan|GSK Investigational Site, Hokkaido, 040-8585, Japan|GSK Investigational Site, Hokkaido, 070-0002, Japan|GSK Investigational Site, Ibaraki, 300-0835, Japan|GSK Investigational Site, Ibaraki, 311-0113, Japan|GSK Investigational Site, Kagawa, 760-0076, Japan|GSK Investigational Site, Kagoshima, 890-0061, Japan|GSK Investigational Site, Kanagawa, 232-0064, Japan|GSK Investigational Site, Kanagawa, 235-0045, Japan|GSK Investigational Site, Kanagawa, 252-0302, Japan|GSK Investigational Site, Kanagawa, 253-0044, Japan|GSK Investigational Site, Kochi, 780-0088, Japan|GSK Investigational Site, Kumamoto, 862-0960, Japan|GSK Investigational Site, Kumamoto, 867-0041, Japan|GSK Investigational Site, Kyoto, 600-8558, Japan|GSK Investigational Site, Kyoto, 601-1495, Japan|GSK Investigational Site, Kyoto, 601-8325, Japan|GSK Investigational Site, Miyagi, 980-0021, Japan|GSK Investigational Site, Miyagi, 985-0852, Japan|GSK Investigational Site, Nagano, 399-0006, Japan|GSK Investigational Site, Nagano, 399-0036, Japan|GSK Investigational Site, Oita, 870-0039, Japan|GSK Investigational Site, Okinawa, 900-0029, Japan|GSK Investigational Site, Osaka, 530-0012, Japan|GSK Investigational Site, Osaka, 536-0023, Japan|GSK Investigational Site, Osaka, 538-0044, Japan|GSK Investigational Site, Osaka, 577-0803, Japan|GSK Investigational Site, Osaka, 582-0019, Japan|GSK Investigational Site, Saitama, 332-0012, Japan|GSK Investigational Site, Saitama, 350-0035, Japan|GSK Investigational Site, Saitama, 350-0851, Japan|GSK Investigational Site, Saitama, 354-0031, Japan|GSK Investigational Site, Saitama, 355-0321, Japan|GSK Investigational Site, Saitama, 358-0011, Japan|GSK Investigational Site, Shizuoka, 424-0855, Japan|GSK Investigational Site, Tochigi, 329-0433, Japan|GSK Investigational Site, Tokyo, 103-0002, Japan|GSK Investigational Site, Tokyo, 103-0027, Japan|GSK Investigational Site, Tokyo, 125-0054, Japan|GSK Investigational Site, Tokyo, 143-0015, Japan
|
