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Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00993720
First received: October 9, 2009
Last updated: January 20, 2011
Last verified: October 2009
History of Changes
  Purpose

The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.


Condition Intervention Phase
Diabetes Mellitus
 Drug: Liraglutide
Other: continuous insulin therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • insulin-dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 24-hours glucose profiles with and without treatment of Victoza [ Time Frame: three days ] [ Designated as safety issue: Yes ]
  • risk of hypoglycemia during physical activity with and without Victoza [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • gastric emptying rate during hypoglycemia with and without Victoza [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • weight change from baseline, change in fructosamine from baseline [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: type 1 DM with betacell function: Liraglutide Drug: Liraglutide
after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.
Experimental: type 1 DM without betacell function: Liraglutide Drug: Liraglutide
after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.
No Intervention: type 1 DM without betacell function: Insulin Other: continuous insulin therapy
after optimal treatment with insulin, patients continue on insulin for four weeks

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-50y,
  • BMI 18-27,
  • caucasian origin,
  • type 1 diabetes diagnosed between age 5 and age 40,
  • no known diabetes complications or cardiovascular diseases,
  • no medication known to influence glucose homeostasis,
  • no pregnancy

Exclusion Criteria:

  • diabetes complications,
  • autonomous nerve dysfunction,
  • anaemia,
  • HbA1c < 8.5% at screening,
  • estimated by the investigator to be incapable of completing the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993720

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sten Madsbad, MD, chief physician, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00993720     History of Changes
Other Study ID Numbers: 2009-001930-80
Study First Received: October 9, 2009
Last Updated: January 20, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
patients with type 1 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 22, 2013