Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes mellitus patients on oral glucose lowering agents, and naive to incretinomimetic. Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day changes in insulin secretion and insulin sensitivity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yaounde Central Hospital
• Collaborators: University of Buea; University of Yaounde 1
• Treatments: Insulin; Insulin, Globin Zinc; Liraglutide; Vildagliptin

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus known for at least one year

• Uncontrolled glycaemic profile with HbA1c ≥ 7% on oral antidiabetic mono or bi-therapy

• Naïve of incretinomimetic treatment

• Informed consent

Exclusion Criteria:

• Change in antidiabetic treatment less than 3 months prior to inclusion

• Pancreatitis

• Alanine amino transferase > 3 times the normal values

• Pregnant or breastfeeding women

• Estimated glomerular filtration rate < 60ml/min

• Infection less than 10 days prior to inclusion or during the study

• Acute complication of diabetes

• Total haemoglobin < 11g/dL in women or < 13g/dL in men

• Withdrawal of consent