Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01147276
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : September 25, 2012
Information provided by (Responsible Party):
Bo Ahren, Lund University

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

Condition or disease Intervention/treatment Phase
Diabetes Hypoglycemia Drug: Vildagliptin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Vildagliptin
Vildagliptin (50 mg BID) given for four weeks
Drug: Vildagliptin
Vildagliptin (50 mg BID) in four weeks
Other Name: Galvus

Primary Outcome Measures :
  1. Glucagon response to hypoglycemia [ Time Frame: 45 min ]
    Change in glucagon from before hypoglycemic clamp until after 45 min

Secondary Outcome Measures :
  1. Catecholamine response to hypoglycemic [ Time Frame: 45 min ]
    Change in catecholamines from before hypolycemic clamp to 45 min

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01147276

Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84
Sponsors and Collaborators
Lund University
Principal Investigator: Bo Ahrén, PhD MD Lund University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bo Ahren, Professor, Lund University Identifier: NCT01147276     History of Changes
Other Study ID Numbers: Lund University Diabetes 002
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Bo Ahren, Lund University:
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents