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

Primary Purpose

Diabetes

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes focused on measuring DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Insulin-treatment, Type 2 diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Lund University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vildagliptin

Arm Description

Vildagliptin (50 mg BID) given for four weeks

Outcomes

Primary Outcome Measures

Glucagon response to hypoglycemia
Change in glucagon from before hypoglycemia clamp until after 45 min

Secondary Outcome Measures

Catecholamine response to hypoglycemia
Change in catecholamines from before hypoglycemic clamp to 45 min

Full Information

First Posted
October 12, 2010
Last Updated
September 29, 2014
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT01219400
Brief Title
Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes
Official Title
Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Insulin-treated Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Insulin-treatment, Type 2 diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Vildagliptin (50 mg BID) given for four weeks
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Other Intervention Name(s)
Galvus, 274901-16-5
Intervention Description
Vildagliptin (50 mg BID) given for four weeks
Primary Outcome Measure Information:
Title
Glucagon response to hypoglycemia
Description
Change in glucagon from before hypoglycemia clamp until after 45 min
Time Frame
45 min
Secondary Outcome Measure Information:
Title
Catecholamine response to hypoglycemia
Description
Change in catecholamines from before hypoglycemic clamp to 45 min
Time Frame
45 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Ahrén, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Study Chair
Facility Information:
Facility Name
Lund University
City
Lund
ZIP/Postal Code
22184
Country
Sweden

12. IPD Sharing Statement

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

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