Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01147276
First received: June 17, 2010
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Diabetes
Hypoglycemia
Drug: Vildagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Glucagon response to hypoglycemia [ Time Frame: 45 min ] [ Designated as safety issue: No ]
    Change in glucagon from before hypoglycemic clamp until after 45 min


Secondary Outcome Measures:
  • Catecholamine response to hypoglycemic [ Time Frame: 45 min ] [ Designated as safety issue: No ]
    Change in catecholamines from before hypolycemic clamp to 45 min


Enrollment: 28
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin
Vildagliptin (50 mg BID) given for four weeks
Drug: Vildagliptin
Vildagliptin (50 mg BID) in four weeks
Other Name: Galvus

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Acute infection
  • Liver disease
  • Treatment with cortisol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147276

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

No publications provided by Lund University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01147276     History of Changes
Other Study ID Numbers: Lund University Diabetes 002
Study First Received: June 17, 2010
Last Updated: September 21, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University:
DPP-4
GLP-1
Glucagon
Catecholamines
Counterregulation
Type 1 diabetes

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

ClinicalTrials.gov processed this record on April 23, 2014