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Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01147276
First Posted: June 22, 2010
Last Update Posted: September 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bo Ahren, Lund University
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Bo Ahren, Lund University:

Primary Outcome Measures:
  • Glucagon response to hypoglycemia [ Time Frame: 45 min ]
    Change in glucagon from before hypoglycemic clamp until after 45 min


Secondary Outcome Measures:
  • Catecholamine response to hypoglycemic [ Time Frame: 45 min ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 17, 2010
First Posted: June 22, 2010
Last Update Posted: September 25, 2012
Last Verified: September 2012

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

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