Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: Vildagliptin

• Registration Number: NCT01219400
• Lead Sponsor: Lund University

Brief Summary

The purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.

Detailed Description

Vildagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and inhibits glucagon secretion and stimulates insulin secretion. This improves glycemia in subjects with type 2 diabetes with a very low risk for hypoglycemia. If hypoglycemia nevertheless develops, it is important that vildagliptin under such conditions does not inhibit glucagon secretion, since that would aggravate the hypoglycemia. It was indeed previously demonstrated in type 2 diabetes that vildagliptin dos not inhibit glucagon secretion during hypoglycemia. This study explores whether vildagliptin affects glucagon counterregulation during hypoglycemia in insulin-treated patients of type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment. The hypoglycemia is induced bvy a standardized clamp procedure.

Study Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Study Start: 2012-01
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Type 2 diabetes
• Insulin treatment
• Age >18 years
• HbA1c <=8.5%

Exclusion Criteria

• Pregnancy
• Lactation
• Acute infection
• Liver disease
• Treatment with cortisol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	Vildagliptin (50 mg BID) given for four weeks

Primary Outcome Measures

Name	Time	Method
Glucagon response to hypoglycemia	45 min	Change in glucagon from before hypoglycemia clamp until after 45 min

Secondary Outcome Measures

Name	Time	Method
Catecholamine response to hypoglycemia	45 min	Change in catecholamines from before hypoglycemic clamp to 45 min

Trial Locations

Locations (1)

Lund University; 🇸🇪 Lund, Sweden