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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01219400
First received: October 12, 2010
Last updated: July 5, 2013
Last verified: July 2013

October 12, 2010
July 5, 2013
January 2012
October 2013   (final data collection date for primary outcome measure)
Glucagon response to hypoglycemia [ Time Frame: 45 min ] [ Designated as safety issue: No ]
Change in glucagon from before hypoglycemia clamp until after 45 min
Same as current
Complete list of historical versions of study NCT01219400 on ClinicalTrials.gov Archive Site
Catecholamine response to hypoglycemia [ Time Frame: 45 min ] [ Designated as safety issue: No ]
Change in catecholamines from before hypoglycemic clamp to 45 min
Same as current
Not Provided
Not Provided
 
Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes
Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Insulin-treated Patients With Type 2 Diabetes

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Diabetes
Drug: Vildagliptin
Vildagliptin (50 mg BID) given for four weeks
Other Names:
  • Galvus
  • 274901-16-5
Experimental: Vildagliptin
Vildagliptin (50 mg BID) given for four weeks
Intervention: Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
28
December 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Insulin treatment
  • Age >18 years
  • HbA1c <=8.5%

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Acute infection
  • Liver disease
  • Treatment with cortisol
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01219400
103
Yes
Bo Ahren, Lund University
Lund University
Not Provided
Study Chair: Bo Ahrén, MD, PhD Lund University
Lund University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP