Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Hypoglycemia
• Interventions: Drug: Vildagliptin

• Registration Number: NCT01147276
• Lead Sponsor: Lund University

Brief Summary

The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

Detailed Description

Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

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

Inclusion Criteria

• Type 1 diabetes
• Age >18 years
• HbA1c 6.5-8,5%

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 hypoglycemic clamp until after 45 min

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Sciences Lund, Lund University; 🇸🇪 Lund, Sweden