| Outcome Measures: |
Primary: Incidence of nocturnal hypoglycemia, Rate of nocturnal (midnight to 06:00 AM) hypoglycemic events (glucose \<54 mg/dL) lasting at least 15 minutes, compared to placebo, During each 28 day treatment period | Secondary: Incidence and severity of adverse events (AEs), Number of patients experiencing AEs compared to placebo, During each 28 day treatment period and 2-week followup|Glucose time below range, Glucose time below 54 mg/dL (as %) compared to placebo, During each 28 day treatment period|Incidence of hypoglycemia, Number of hypoglycemic events (glucose \<70 mg/dL for at least 15 minutes, compared to placebo, During each 28 day treatment period | Other: Glucose time in range, Glucose time in range (70-180 mg/dL, %) compared to placebo, During each 28-day treatment period|Mean glycemic variability, Percent coefficient of variation of glucose values compared to placebo, During each 28 day treatment period|Mean glucose concentration, Mean glucose concentration compared to placebo, During each 28 day treatment period
|
| Locations: |
Headlands Research, Escondido, California, 92025, United States|USC Keck Medicine Eastside Center for Diabetes, Los Angeles, California, 90022, United States|LCGK Research, San Carlos, California, 94070, United States|East Coast Institute for Research LLC, Jacksonville, Florida, 32216, United States|Suncoast Clinical Research, New Port Richey, Florida, 34652, United States|Hanson Diabetes Center, Port Charlotte, Florida, 33952, United States|Metabolic Research Institute, West Palm Beach, Florida, 33401, United States|East Coast Institute for Research, Macon, Georgia, 31210, United States|IU Health University Hospital, Indianapolis, Indiana, 46202, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|MedStar Good Samaritan Hospital, Baltimore, Maryland, 21239, United States|Palm Research Center, Inc., Las Vegas, Nevada, 89148, United States|Albany Medical Center, Albany, New York, 12203, United States|Lucas Research Inc., Morehead City, North Carolina, 28557, United States|University Diabetes & Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Texas Diabetes & Endocrinology, PA, Austin, Texas, 78749, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Diabetes & Glandular Disease Clinic, San Antonio, Texas, 78229, United States|Centricity Research Calgary Endocrinology, Calgary, Alberta, T2H 2G4, Canada|BC Diabetes, Vancouver, British Columbia, V5Y 3W2, Canada|Centricity Research Barrie Endocrinology, Barrie, Ontario, L4N 7L3, Canada|Centricity Research Vaughan Endocrinology, Concord, Ontario, L4K 4M2, Canada|Centricity Research Etobicoke Endocrinology, Etobicoke, Ontario, M9R 4E1, Canada|Centricity Research Toronto, Toronto, Ontario, M4G 3E8, Canada|Mount Sinai Hospital: Leadership Sinai Centre for Diabetes, Toronto, Ontario, M5T 3L9, Canada
|
