Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus
Started Oct 2009
Shorter than P25 for phase_2 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJanuary 21, 2011
October 1, 2009
1 year
October 9, 2009
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin-dose
4 weeks
Secondary Outcomes (4)
24-hours glucose profiles with and without treatment of Victoza
three days
risk of hypoglycemia during physical activity with and without Victoza
one day
gastric emptying rate during hypoglycemia with and without Victoza
one day
weight change from baseline, change in fructosamine from baseline
four weeks
Study Arms (3)
type 1 DM with betacell function: Liraglutide
EXPERIMENTALtype 1 DM without betacell function: Liraglutide
EXPERIMENTALtype 1 DM without betacell function: Insulin
NO INTERVENTIONInterventions
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.
after optimal treatment with insulin, patients continue on insulin for four weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- diabetes complications,
- autonomous nerve dysfunction,
- anaemia,
- HbA1c \< 8.5% at screening,
- estimated by the investigator to be incapable of completing the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre University Hospital
Hvidovre, 2650, Denmark
Related Publications (1)
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.
PMID: 21593296DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 12, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
January 21, 2011
Record last verified: 2009-10