Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 9, 2009
January 20, 2011
October 2009
October 2010   (final data collection date for primary outcome measure)
insulin-dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00993720 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • 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.
  • 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.
  • Other: continuous insulin therapy
    after optimal treatment with insulin, patients continue on insulin for four weeks
  • Experimental: type 1 DM with betacell function: Liraglutide
    Intervention: Drug: Liraglutide
  • Experimental: type 1 DM without betacell function: Liraglutide
    Intervention: Drug: Liraglutide
  • No Intervention: type 1 DM without betacell function: Insulin
    Intervention: Other: continuous insulin therapy
Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011 Jul;34(7):1463-8. doi: 10.2337/dc11-0096. Epub 2011 May 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00993720
2009-001930-80
Yes
Sten Madsbad, MD, chief physician, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Not Provided
Hvidovre University Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP