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

This study is not yet open for participant recruitment.
Verified June 2011 by Lund University
Sponsor:
Information provided by:
Lund University
ClinicalTrials.gov Identifier:
NCT01219400
First received: October 12, 2010
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
 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 Insulin-treated Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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 hypoglycemia clamp until after 45 min


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


Estimated Enrollment: 28
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (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) given for four weeks
Other Names:
  • Galvus
  • 274901-16-5

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219400

Contacts
Contact: Bo Ahrén, MD, PhD +46462220758 Bo.Ahren@med.lu.se
Contact: Margaretha Persson, PhD +4640332037 Margaretha.Persson@med.lu.se

Locations
Sweden
Lund University Not yet recruiting
Lund, Sweden, 22184
Contact: Bo Ahrén, MD PhD     +46462220758     Bo.Ahren@med.lu.se    
Contact: Margaretha Persson, PhD     04640332037     Margaretha.Persson@med.lu.se    
Principal Investigator: Bo Ahrén, MD PhD            
Sponsors and Collaborators
Lund University
Investigators
Study Chair: Bo Ahrén, MD, PhD Lund University
  More Information

No publications provided

Responsible Party: Bo Ahrén/Professor, Lund University
ClinicalTrials.gov Identifier: NCT01219400     History of Changes
Other Study ID Numbers: 103
Study First Received: October 12, 2010
Last Updated: June 23, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University:
DPP-4
GLP-1
Glucagon
Catecholamines
 Counterregulation
Insulin-treatment
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Vildagliptin
Insulin
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins
Hypoglycemic Agents
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013