Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7069
Source ID: NCT01524705
Associated Drug: Insulin Glargine
Title: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)
Acronym: FLAT-SUGAR
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01524705/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin Glargine|DRUG: Metformin|DRUG: Prandial insulin|DRUG: Exenatide
Outcome Measures: Primary: Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline, The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM), At baseline, 6 months of intervention | Secondary: Number of Participants With Hypoglycemia, Severe hypoglycemia-documented glucose \<50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel., 26 weeks|Weight Change During Trial, Weight in kg at 26 weeks minus weight at baseline., Baseline vs 26 weeks | Other: HbA1C Levels, % of glycosylated hemoglobin in whole blood at 26 weeks, Baseline vs 26 weeks
Sponsor/Collaborators: Sponsor: University of Washington | Collaborators: Eli Lilly and Company|Sanofi|Astra Zeneca, Bristol-Myers Squibb|DexCom, Inc.|Bayer|Becton, Dickinson and Company|Medicomp|University of Texas|US Department of Veterans Affairs|Biomedical Research Institute of New Mexico
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 102
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2012-08
Completion Date: 2014-07
Results First Posted: 2023-12-29
Last Update Posted: 2023-12-29
Locations: So Calif. Permanente Medical Group, San Diego, California, 92109, United States|University of Miami, Miami, Florida, 33136, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Washington University, Saint Louis, Missouri, 63110, United States|Kaledia Health of Western New York, Buffalo, New York, 14209, United States|Diabetes Care Center, Durham, North Carolina, 27713, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|University of Vermont, Colchester, Vermont, 05446, United States|University of Washington, Seattle, Washington, 98105, United States|Washington State University Spokane, College of Pharmacy Spokane WA 99202 USA, Spokane, Washington, 99202, United States
URL: https://clinicaltrials.gov/show/NCT01524705