NCT01654120

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Mountain Diabetes and Endocrine Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Interventions

Type	Name	Description
DRUG	Liraglutide	SC, 1.8mg,QD, six months to one year
DRUG	Insulin	SC, will be titrated during the study, 4 times a day, 1 year

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-07-31
• Last updated: 2021-02-25

Locations

1 site across 1 country: United States