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

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.
 
ClinicalTrials.gov Identifier: NCT00993720
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : January 21, 2011
Sponsor:
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE October 9, 2009
First Posted Date  ICMJE October 12, 2009
Last Update Posted Date January 21, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
insulin-dose [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
  • 24-hours glucose profiles with and without treatment of Victoza [ Time Frame: three days ]
  • risk of hypoglycemia during physical activity with and without Victoza [ Time Frame: one day ]
  • gastric emptying rate during hypoglycemia with and without Victoza [ Time Frame: one day ]
  • weight change from baseline, change in fructosamine from baseline [ Time Frame: four weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Official Title  ICMJE Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00993720
Other Study ID Numbers  ICMJE 2009-001930-80
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sten Madsbad, MD, chief physician, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hvidovre University Hospital
Verification Date October 2009

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