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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01219400
First received: October 12, 2010
Last updated: September 29, 2014
Last verified: September 2014
  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:


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


Enrollment: 28
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219400

Locations
Sweden
Lund University
Lund, Sweden, 22184
Sponsors and Collaborators
Lund University
Investigators
Study Chair: Bo Ahrén, MD, PhD Lund University
  More Information

No publications provided

Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01219400     History of Changes
Other Study ID Numbers: 103
Study First Received: October 12, 2010
Last Updated: September 29, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Insulin
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014