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Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Information source: Lund University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Hypoglycemia

Intervention: Vildagliptin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Lund University

Official(s) and/or principal investigator(s):
Bo Ahrén, PhD MD, Principal Investigator, Affiliation: Lund University


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

Clinical Details

Official title: Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Glucagon response to hypoglycemia

Secondary outcome: Catecholamine response to hypoglycemic

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Type 1 diabetes

- Age >18 years

- HbA1c 6. 5-8,5%

Exclusion Criteria:

- Pregnancy

- Lactation

- Acute infection

- Liver disease

- Treatment with cortisol

Locations and Contacts

Department of Clinical Sciences Lund, Lund University, Lund 221 84, Sweden
Additional Information

Starting date: September 2010
Last updated: September 21, 2012

Page last updated: August 23, 2015

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