Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics

NCT ID: NCT01654120


Title
Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes
Purpose
The purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated Type 2 diabetes with insulin requirements of > 100 units of insulin per day.
Details
40 subjects with Type 2 diabetes using > 100 units of insulin per day with or without metformin with HbA1c > 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.
Conditions
Diabetes Mellitus, Type II
Keywords
insulin, Type II Diabetes, liraglutide, Glucagon-Like Peptide 1
Source
Mountain Diabetes and Endocrine Center
Sponsors
Mountain Diabetes and Endocrine Center
Status
Completed
Acronym
Last Updated
15 Apr 2015
URL
Official Link
Locations
United States