| Outcome Measures: |
Primary: Change From Baseline in HbA1c to Week 26, Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework., Baseline, Week 26 | Secondary: Mean Change From Baseline in Body Weight to Week 26, Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework., Baseline, Week 26|Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26, The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders., Week 26|Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26, The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders., Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26, Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework., Baseline, Week 26|Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26, Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal., Baseline, Week 26|Percentage of Participants Requiring Rescue Therapy, Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG \>270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG \>13.3 mmol/L, and from Week 14 to Week 26: FPG \>11.1 mmol/L or HbA1c\>8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors., Baseline up to 26 weeks|Change From Baseline in Beta-Cell Function to Week 26, Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20\*FPI \[micro units/milliliter\]) divided by (FPG \[mmol/L\] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value\*100., Baseline, Week 26|Change From Baseline in Insulin Resistance to Week 26, Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI \[micro units per milliliter\] \* FPG \[mmol/L\]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value., Baseline, Week 26|Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences, Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated., Baseline,Week 26
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| Locations: |
Investigational Site Number 8400028, Sheffield, Alabama, 35660, United States|Investigational Site Number 8400002, Huntington Park, California, 90255, United States|Investigational Site Number 8400024, Los Angeles, California, 90017, United States|Investigational Site Number 8400001, Los Angeles, California, 90057, United States|Investigational Site Number 8400012, Port Hueneme, California, 93041, United States|Investigational Site Number 8400027, Denver, Colorado, 80209, United States|Investigational Site Number 8400025, Miami, Florida, 33166, United States|Investigational Site Number 8400007, Palm Harbor, Florida, 34684, United States|Investigational Site Number 8400013, Chicago, Illinois, 60827, United States|Investigational Site Number 8400016, Wichita, Kansas, 67205, United States|Investigational Site Number 8400023, Wichita, Kansas, 67207, United States|Investigational Site Number 8400018, New Orleans, Louisiana, 70119, United States|Investigational Site Number 8400019, Rockville, Maryland, 20852, United States|Investigational Site Number 8400014, Flint, Michigan, 48532-3447, United States|Investigational Site Number 8400003, Troy, Michigan, 48085, United States|Investigational Site Number 8400020, Linden, New Jersey, 07036, United States|Investigational Site Number 8400022, New York, New York, 10001, United States|Investigational Site Number 8400005, Fargo, North Dakota, 58103, United States|Investigational Site Number 8400004, Austin, Texas, 78731, United States|Investigational Site Number 8400006, Dallas, Texas, 75230, United States|Investigational Site Number 8400021, Houston, Texas, 77079, United States|Investigational Site Number 8400026, San Antonio, Texas, 78229, United States|Investigational Site Number 8400017, Sugar Land, Texas, 77478, United States|Investigational Site Number 1240008, Quebec, G1S 2L6, Canada|Investigational Site Number 1240005, Sainte-Foy, G1W4R4, Canada|Investigational Site Number 1240002, Sherbrooke, J1L 0H8, Canada|Investigational Site Number 1240001, Toronto, M4G 3E8, Canada|Investigational Site Number 1240003, Vancouver, V5Y 3W2, Canada|Investigational Site Number 2030003, Ceske Budejovice, 370 01, Czechia|Investigational Site Number 2030001, Krnov, 79401, Czechia|Investigational Site Number 2030004, Praha 10 - Uhrineves, 104 00, Czechia|Investigational Site Number 2030002, Praha 9 - Klanovice, 19014, Czechia|Investigational Site Number 2760003, Berlin, 10115, Germany|Investigational Site Number 2760001, Dresden, 01307, Germany|Investigational Site Number 2760006, Hohenmölsen, 06679, Germany|Investigational Site Number 3480001, Balatonfüred, 8230, Hungary|Investigational Site Number 3480002, Budapest, 1027, Hungary|Investigational Site Number 3480008, Budapest, 1042, Hungary|Investigational Site Number 3480005, Budapest, 1062, Hungary|Investigational Site Number 3480006, Budapest, 1062, Hungary|Investigational Site Number 3480007, Budapest, 1213, Hungary|Investigational Site Number 4840004, Actopan, 42500, Mexico|Investigational Site Number 4840001, Guadalajara, 44600, Mexico|Investigational Site Number 4840003, Guadalajara, 44670, Mexico|Investigational Site Number 4840002, Monterrey, 64460, Mexico|Investigational Site Number 4840006, San Juan Del Rio, 76800, Mexico|Investigational Site Number 6430003, Saratov, 410030, Russian Federation|Investigational Site Number 6430002, St-Petersburg, 190068, Russian Federation|Investigational Site Number 6430001, St-Petersburg, 195257, Russian Federation|Investigational Site Number 6430004, St. Petersburg, 194358, Russian Federation|Investigational Site Number 6430005, Voronezh, 394018, Russian Federation|Investigational Site Number 7240005, Barcelona, 08035, Spain|Investigational Site Number 7240007, Ferrol, 15405, Spain|Investigational Site Number 7240001, La Coruña, 15006, Spain|Investigational Site Number 7240006, Las Palmas De Gran Canaria, 35016, Spain|Investigational Site Number 7240002, Madrid, 28040, Spain|Investigational Site Number 7240003, Málaga, 29010, Spain|Investigational Site Number 7240004, Málaga, 29010, Spain|Investigational Site Number 7240008, Sevilla, 41071, Spain
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