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

NCT ID: NCT01219400

Last Updated: 2014-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Vildagliptin

Vildagliptin (50 mg BID) given for four weeks

Group Type: EXPERIMENTAL

Vildagliptin

Intervention Type: DRUG

Vildagliptin (50 mg BID) given for four weeks

Interventions

Vildagliptin

Vildagliptin (50 mg BID) given for four weeks

Intervention Type: DRUG

Other Intervention Names

Galvus; 274901-16-5

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Bo Ahren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Ahrén, MD, PhD

Role: STUDY_CHAIR

Lund University

Locations

Lund University

Lund, , Sweden

Countries

Sweden

Other Identifiers

103

Identifier Type: -

Identifier Source: org_study_id