| Outcome Measures: |
Primary: Change in HbA1c From Baseline to Week 24, Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP)., Baseline, Week 24 | Secondary: Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24, The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP., Baseline, Week 24|Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24, 2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP., Baseline, Week 24|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24, Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP., Baseline, Week 24|Change in Body Weight From Baseline to Week 24, Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP., Baseline, Week 24|Average Daily Insulin Glargine Dose at Week 24, Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP., Week 24|Change in FPG From Baseline to Week 24, Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP., Baseline, Week 24|Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period, Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8%., Baseline up to Week 24|Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24, On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP., Week 24|Change in 30-minute and 1-hour PPG From Baseline to Week 24, The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP., Baseline, Week 24|Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24, 30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP., Baseline, Week 24|Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP., Baseline up to Week 24|Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24, Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data., Week 24|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others., First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)
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| Locations: |
Investigational Site Number 840408, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840412, Paramount, California, 90723, United States|Investigational Site Number 840401, Larenceville, Georgia, 30045, United States|Investigational Site Number 840417, Roswell, Georgia, 30076, United States|Investigational Site Number 840403, Lexington, Kentucky, 40504, United States|Investigational Site Number 840404, Hyattsville, Maryland, 20782, United States|Investigational Site Number 840405, Rockville, Maryland, 20852, United States|Investigational Site Number 840411, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840415, West Seneca, New York, 14224, United States|Investigational Site Number 840402, Norman, Oklahoma, 73069, United States|Investigational Site Number 840407, Medford, Oregon, 97504, United States|Investigational Site Number 840413, Durham, Pennsylvania, 27713, United States|Investigational Site Number 840410, Dallas, Texas, 75230, United States|Investigational Site Number 840414, Renton, Washington, 98055, United States|Investigational Site Number 152404, Santiago, 7500347, Chile|Investigational Site Number 152405, Santiago, 7500347, Chile|Investigational Site Number 152403, Santiago, 7500710, Chile|Investigational Site Number 152401, Santiago, 7980378, Chile|Investigational Site Number 152402, Santiago, 8320000, Chile|Investigational Site Number 203403, Novy Jicin, 74101, Czech Republic|Investigational Site Number 203401, Plzen, 32600, Czech Republic|Investigational Site Number 203402, Praha 2, 12808, Czech Republic|Investigational Site Number 203405, Praha 8, 18100, Czech Republic|Investigational Site Number 208401, København Nv, 2400, Denmark|Investigational Site Number 208404, Køge, 4600, Denmark|Investigational Site Number 208402, Slagelse, 4200, Denmark|Investigational Site Number 208403, Svendborg, 5700, Denmark|Investigational Site Number 250402, Narbonne, 11018, France|Investigational Site Number 250404, Poitiers Cedex, 86021, France|Investigational Site Number 250401, Vandoeuvre Les Nancy, 54511, France|Investigational Site Number 276401, Dresden, 01307, Germany|Investigational Site Number 276402, Ludwigshafen, 67059, Germany|Investigational Site Number 276403, Oberhausen, 46045, Germany|Investigational Site Number 348401, Balatonfüred, 8230, Hungary|Investigational Site Number 348405, Budapest, 1041, Hungary|Investigational Site Number 348406, Budapest, 1212, Hungary|Investigational Site Number 348404, Debrecen, 4043, Hungary|Investigational Site Number 348402, Szeged, 6720, Hungary|Investigational Site Number 348403, Szeged, 6722, Hungary|Investigational Site Number 440401, Kaunas, LT-49456, Lithuania|Investigational Site Number 440402, Kaunas, LT-51270, Lithuania|Investigational Site Number 440403, Kedainiai, LT-57164, Lithuania|Investigational Site Number 440404, Klaipeda, LT-92304, Lithuania|Investigational Site Number 484404, Acapulco, 39670, Mexico|Investigational Site Number 484401, Cuernavaca, 62250, Mexico|Investigational Site Number 484405, Durango, 34270, Mexico|Investigational Site Number 484402, Guadalajara, 44210, Mexico|Investigational Site Number 484403, Guadalajara, 44656, Mexico|Investigational Site Number 616405, Bialystok, 15-435, Poland|Investigational Site Number 616406, Gdansk, 80-847, Poland|Investigational Site Number 616403, Krakow, 31-548, Poland|Investigational Site Number 616407, Lodz, 94-074, Poland|Investigational Site Number 616404, Pulawy, 24-100, Poland|Investigational Site Number 616402, Szczecin, 70-506, Poland|Investigational Site Number 616401, Warszawa, 02-507, Poland|Investigational Site Number 642402, Brasov, 500365, Romania|Investigational Site Number 642403, Bucuresti, 020475, Romania|Investigational Site Number 642405, Iasi, 700547, Romania|Investigational Site Number 642401, Oradea, 410169, Romania|Investigational Site Number 642406, Targu Mures, 540142, Romania|Investigational Site Number 642404, Timisoara, 300133, Romania|Investigational Site Number 703402, Bratislava, 85101, Slovakia|Investigational Site Number 703403, Kosice, 04001, Slovakia|Investigational Site Number 703406, Kosice, 04013, Slovakia|Investigational Site Number 703404, Moldava Nad Bodvou, 04525, Slovakia|Investigational Site Number 703405, Nitra, 94911, Slovakia|Investigational Site Number 703401, Zilina, 01001, Slovakia|Investigational Site Number 752402, Skellefteå, 931 32, Sweden|Investigational Site Number 752401, Stockholm, 171 76, Sweden|Investigational Site Number 752403, Växjö, 351 85, Sweden
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