| Outcome Measures: |
Primary: Change in incidence of Level 2 or Level 3 hypoglycemia, Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo., 26 weeks | Secondary: To assess the change in HbA1c, Change from baseline in HbA1c in participants on cadisegliatin vs placebo., 26 weeks|To assess the effects of treatment on CGM-based metrics for glycemic control, To evaluate the change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo, 26 weeks|To assess the effects of treatment on the incidence of diabetic ketoacidosis, Number of events of diabetic ketoacidosis participants on cadisegliatin vs placebo, 26 weeks|To assess the effects of treatment on insulin dosing, Change from baseline in basal, bolus and total insulin dosing, 26 weeks|To assess the effects of treatment on body weight, Change from baseline in mean body weight, 26 weeks|To assess the incidence of adverse events, Evaluation and comparison of the number of adverse events with cadisegliatin vs placebo during the study, 26 weeks | Other: Change in incidence of Level 2 or Level 3 hypoglycemia, Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo., 52 weeks|To assess the change in HbA1c, Change from baseline in HbA1c in participants on cadisegliatin vs placebo, 52 weeks|To assess the effects of treatment on CGM-based metrics for glycemic control, To evaluate the change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo, 52 weeks|To assess the incidence of adverse events, Evaluation and comparison of the number of adverse events with cadisegliatin vs placebo during the study, 52 weeks|To assess the effects of treatment on the incidence of diabetic ketoacidosis, Percentage of participants with incidence of diabetic ketoacidosis on cadisegliatin vs placebo, 52 weeks|To assess the effects of treatment on insulin dosing, Change from baseline in basal, bolus and total insulin dosing, 52 weeks|To assess the effects of treatment on body weight, Change from baseline in mean body weight, 52 weeks|High sensitivity C-reactive protein, Change from baseline of biomarkers, 26 and 52 weeks|N-terminal pro brain [or B-type] natriuretic peptide, Change from baseline of biomarkers, 26 and 52 weeks|Urinary albumin excretion ratio, Change from baseline of biomarkers, 26 and 52 weeks|Estimated glomerular filtration rate, Change from baseline of biomarkers, 26 and 52 weeks|Gold hypoglycemia awareness score, Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from 1 (always aware) to 7 (never aware)., 26 and 52 weeks|Item 7 of Clarke hypoglycemia awareness scale, Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from less than 40 mg/dL to 79mg/dL., 26 and 52 weeks|Snyder's 1-item quality of sleep questionnaire, Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from 0 (terrible) to 10 (excellent)., 26 and 52 weeks|World Health Organization-5 Well-Being Index, Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Ranges from not confident to very confident., 26 and 52 weeks|8-item Diabetes Distress Scale (participant and partner or family member), Change from baseline in PRO scores to assess the burden of hypoglycemia, 26 and 52 weeks|Hypoglycemia Confidence Scale for participant and partner or family member, Change from baseline in PRO scores to assess the burden of hypoglycemia, 26 and 52 weeks|11-item/Short Form Hypoglycemia Fear Scale, Change from baseline in PRO scores to assess the burden of hypoglycemia, 26 and 52 weeks
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| Locations: |
Advanced Metabolic Care & Research Institute, Inc. (AMCR), Escondido, California, 92025, United States|Denver Endocrinology Diabetes and Thyroid Center, Englewood, Colorado, 80113, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|Metabolic Research Institute, Inc, West Palm Beach, Florida, 33413, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Centricity Research - Columbus, Columbus, Georgia, 31904, United States|Endocrine Research Solutions, Inc, Roswell, Georgia, 30076, United States|Iowa Diabetes Research, West Des Moines, Iowa, 50265, United States|Asheville Clinical Research, Asheville, North Carolina, 28803, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States|Lucas Research, Inc, Morehead City, North Carolina, 28557, United States|Velocity Clinical Research - Medford, Medford, Oregon, 97504, United States|Texas Diabetes and Endocrinology, P.A, Austin, Texas, 78731, United States|Velocity Clinical Research - Dallas, Dallas, Texas, 75230, United States|Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States|Advanced Research Institute - Ogden, Ogden, Utah, 84405, United States
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