| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug., Baseline, Week 16 | Secondary: Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16, A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug., Baseline, Week 16|Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16, A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug., Baseline, Week 16|Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16, Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares)., Week 16|Rate of Severe Hypoglycemia at Week 16, Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group \*36525., Baseline through Week 16|Rate of Documented Symptomatic Hypoglycemia at Week 16, Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of \<54 mg/dL \[3.0 millimole per liter (mmol/L)\]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable., Baseline through Week 16|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16, 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug., Baseline, Week 16|Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16, SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (\>)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug., Baseline, Week 16|Change From Baseline in Insulin Dose at Week 16, LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug., Baseline, Week 16|Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16, The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug., Baseline, Week 16|Percentage of Participants With HbA1c <7%, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Week 16|Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change, Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated., Baseline through Week 16|Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change, Percentage of participants with at least 1 event of unexplained hyperglycemia \>300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated., Baseline through Week 16
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| Locations: |
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Valley Research, Fresno, California, 93720, United States|Marin Endocrine Associates, Greenbrae, California, 94904, United States|Diabetes and Endocrine Associates, La Mesa, California, 91942, United States|First Valley Medical Group, Lancaster, California, 93534, United States|Center of Excellence in Diabetes & Endocrinology, Sacramento, California, 95821, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Coastal Metabolic Research Centre, Ventura, California, 93003, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|Sun Coast Clinical Research, Inc, New Port Richey, Florida, 34652, United States|Metabolic Research Institute Inc., West Palm Beach, Florida, 33401, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|East West Medical Institute, Honolulu, Hawaii, 96814, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Northwestern Feinberg School of Medicine, Chicago, Illinois, 60611, United States|Prairie Education and Research Cooperative, Springfield, Illinois, 62711, United States|Iderc, P.L.C., West Des Moines, Iowa, 50265, United States|Kentucky Diabetes Endocrinology Center, Lexington, Kentucky, 40503, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Palm Research Center, Las Vegas, Nevada, 89128, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|Physicians East, Greenville, North Carolina, 27843, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States|Texas Diabetes and Endocrinology-Austin South, Austin, Texas, 78749, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Texas Diabetes and Endocrinology, P.A., Round Rock, Texas, 78681, United States|Private: Dr. Larry Stonesifer, Federal Way, Washington, 98003, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Tacoma Center for Arthritis Research, PS, Tacoma, Washington, 98405, United States|The AIM Centre, Merewether, New South Wales, 2291, Australia|GP Plus Marion, Oaklands Park, South Australia, 5046, Australia|Box Hill Hospital, Box Hill, Victoria, 3128, Australia|Barwon Health - The Geelong Hospital, Geelong, Victoria, 3220, Australia|Fremantle Hospital, Fremantle, Western Australia, 6160, Australia|Universitätsklinikum Graz, Graz, Steiermark, 8036, Austria|VIVIT Institut am LKH Feldkirch, Feldkirch, Vorarlberg, 6800, Austria|Universitätsklinikum Salzburg, Salzburg, 5020, Austria|KA Rudolfstiftung, Vienna, 1030, Austria|LMC Endocrinology Centres Ltd., Barrie, Ontario, L4N 7L3, Canada|LMC Endocrinology Centres Ltd., Concord, Ontario, L4K 4M2, Canada|LMC Endocrinology Centres, Oakville, Ontario, L6M 4H8, Canada|LMC Endocrinology Centres Ltd., Toronto, Ontario, M4G 3E8, Canada|IRCM, Montreal, Quebec, H2W 1R7, Canada|LMC Endocrinology Centres Ltd., Ville St-Laurent, Quebec, H4T 1Z9, Canada|CHU Toulouse Hopital de Rangueil, Toulouse, Cedex 9, 31059, France|Clinique Hotel Dieu, Le Creusot, 71200, France|Centre hospitalier universitaire Lapeyronie, Montpellier Cedex 5, 34295, France|Hopital Cochin, Paris CEDEX 14, 75679, France|Hôpital de HautePierre, Strasbourg, 67098, France|Groupe hospitalier mutualiste Les Portes du sud, Venissieux, 69200, France|Arztpraxis Dr. Cornelia Marck, Pohlheim, Hessen, 35415, Germany|Institut für Diabetesforschung Münster GmbH, Münster, Nordrhein-Westfalen, 48145, Germany|Praxis Dr. Kempe - Dr. Stemler, Ludwigshafen am Rhein, Rheinland-Pfalz, 67059, Germany|Schwerpunktpraxis Diabetes, Saint Ingbert-Oberwürzbach, Saarland, 66386, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|Diabetespraxis Prenzlauer Allee, Berlin, 10409, Germany|Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen, Hamburg, 21073, Germany|Gemeinschaftspraxis für innere Medizin und Diabetologie, Hamburg, 22607, Germany|Budai Irgalmasrendi Korhaz, Budapest, 1023, Hungary|ClinDiab Kft., Budapest, 1089, Hungary|UNO Medical Trials Kft., Budapest, 1135, Hungary|TRANTOR 99 Bt., Budapest, 1213, Hungary|Soroka Medical Center - Pediatric Outpatient Clinic, Beer-Sheva, 8410101, Israel|Rambam Health Care Campus, Haifa, 31096, Israel|Hadassah Medical Center, Jerusalem, 91120, Israel|Schneider Medical Center, Petah Tiqva, 4920235, Israel|Sheba Medical Center, Ramat Gan, 5266202, Israel|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24128, Italy|IRCCS Ospedale San Raffaele, Milano, 20132, Italy|Ospedale San Giovanni di Dio, Olbia, 07026, Italy|Ospedale Santa Maria delle Croci, Ravenna, 48121, Italy|Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza, Roma, 00161, Italy|Advanced Clinical Research, LLC, Bayamon, 00961, Puerto Rico|Centro de Endocrinologia Alcantara Gonzalez, Lomas Verdes, 00956, Puerto Rico|Corporació Sanitaria Parc Tauli, Sabadell, Barcelona, 08208, Spain|Hospital Universitari Arnau de Vilanova, Lleida, Cataluña, 25198, Spain|Hospital Clinic I Provincial, Barcelona, 08036, Spain|Hospital Universitario La Paz, Madrid, 28046, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain
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