We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Liraglutide Other: continuous insulin therapy Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. insulin-dose [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 24-hours glucose profiles with and without treatment of Victoza [ Time Frame: three days ]
  2. risk of hypoglycemia during physical activity with and without Victoza [ Time Frame: one day ]
  3. gastric emptying rate during hypoglycemia with and without Victoza [ Time Frame: one day ]
  4. weight change from baseline, change in fructosamine from baseline [ Time Frame: four weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00993720


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

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
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: October 2009

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, Globin Zinc
Insulin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists