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Clinical Trial Details

Trial ID: L1842
Source ID: NCT01654120
Associated Drug: Liraglutide
Title: Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: Liraglutide|DRUG: Insulin
Outcome Measures: Primary: Change from baseline in HbA1c at six months, Glycemic control as measured by HbA1c, baseline and six months | Secondary: Hypoglycemia, The frequency and severity of hypoglycemia in each treatment arm by glucose meter download and by percent time spent in the hypoglycemic range (BG \< 70 mg/dl) by CGM will be assessed at six and 12 months, 6 months and 12 months|Total Daily Insulin Dose (TDID), TDID will be determined in each treatment arm for statistical comparisons at three and six months, and for entire cohort at nine and 12 months., 3, 6, 9, and 12 months|Weight, Weight will be statistically compared to baseline and between treatment arms at three and six months, and for entire cohort between baseline, six, nine and 12 months., baseline, 3, 6, 9, and 12 months|GlycoMark, Postprandial glycemic control as assessed by GlycoMark and CGM will be compared between study groups at three and six months, and for entire cohort compared to baseline at nine and 12 months., baseline, 3, 6, 9, and 12 months
Sponsor/Collaborators: Sponsor: Mountain Diabetes and Endocrine Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 37
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12
Completion Date: 2013-11
Results First Posted:
Last Update Posted: 2021-02-25
Locations: Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
URL: https://clinicaltrials.gov/show/NCT01654120