Back to resultsEffect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Liraglutide
Liraglutide
continuous insulin therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring patients with type 1 diabetes mellitus
Eligibility 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.
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
type 1 DM with betacell function: Liraglutide
type 1 DM without betacell function: Liraglutide
type 1 DM without betacell function: Insulin
Arm Description
Outcomes
Primary Outcome Measures
insulin-dose
Secondary Outcome Measures
24-hours glucose profiles with and without treatment of Victoza
risk of hypoglycemia during physical activity with and without Victoza
gastric emptying rate during hypoglycemia with and without Victoza
weight change from baseline, change in fructosamine from baseline
Full Information
NCT ID
NCT00993720
First Posted
October 9, 2009
Last Updated
January 20, 2011
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00993720
Brief Title
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Official Title
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
patients with type 1 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
type 1 DM with betacell function: Liraglutide
Arm Type
Experimental
Arm Title
type 1 DM without betacell function: Liraglutide
Arm Type
Experimental
Arm Title
type 1 DM without betacell function: Insulin
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
continuous insulin therapy
Intervention Description
after optimal treatment with insulin, patients continue on insulin for four weeks
Primary Outcome Measure Information:
Title
insulin-dose
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
24-hours glucose profiles with and without treatment of Victoza
Time Frame
three days
Title
risk of hypoglycemia during physical activity with and without Victoza
Time Frame
one day
Title
gastric emptying rate during hypoglycemia with and without Victoza
Time Frame
one day
Title
weight change from baseline, change in fructosamine from baseline
Time Frame
four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21593296
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
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