Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Lund University

Status and phase: Completed; Phase 4

Conditions: Hypoglycemia; Diabetes

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01147276

Lund University Diabetes 002

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 1 patient group

Vildagliptin

Experimental group

Description:

Vildagliptin (50 mg BID) given for four weeks

Treatment:

Drug: Vildagliptin