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Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Primary Purpose

Diabetes, Hypoglycemia

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, Type 1 diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Clinical Sciences Lund, 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 hypoglycemic clamp until after 45 min

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2010
Last Updated
September 21, 2012
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT01147276
Brief Title
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
Official Title
Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (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 study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypoglycemia
Keywords
DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Type 1 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
Intervention Description
Vildagliptin (50 mg BID) in four weeks
Primary Outcome Measure Information:
Title
Glucagon response to hypoglycemia
Description
Change in glucagon from before hypoglycemic clamp until after 45 min
Time Frame
45 min
Secondary Outcome Measure Information:
Title
Catecholamine response to hypoglycemic
Description
Change in catecholamines from before hypolycemic clamp to 45 min
Time Frame
45 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Ahrén, PhD MD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Sciences Lund, Lund University
City
Lund
ZIP/Postal Code
221 84
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22855332
Citation
Farngren J, Persson M, Schweizer A, Foley JE, Ahren B. Vildagliptin reduces glucagon during hyperglycemia and sustains glucagon counterregulation during hypoglycemia in type 1 diabetes. J Clin Endocrinol Metab. 2012 Oct;97(10):3799-806. doi: 10.1210/jc.2012-2332. Epub 2012 Aug 1.
Results Reference
derived

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Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

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