Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01147276
First received: June 17, 2010
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.


Condition Intervention Phase
Diabetes
Hypoglycemia
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 Patients With Type 1 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 hypoglycemic clamp until after 45 min


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


Enrollment: 28
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (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) in four weeks
Other Name: Galvus

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01147276

Locations
Sweden
Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Bo Ahrén, PhD MD Lund University
  More Information

No publications provided by Lund University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01147276     History of Changes
Other Study ID Numbers: Lund University Diabetes 002
Study First Received: June 17, 2010
Last Updated: September 21, 2012
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on September 22, 2014