| Trial ID: | L3758 |
| Source ID: | NCT01612468
|
| Associated Drug: |
Liraglutide
|
| Title: |
Liraglutide in Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Overweight
|
| Interventions: |
DRUG: Liraglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c, To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an adjunctive therapy to insulin treatment., 24 week | Secondary: Body weight, To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in weight, BMI and body composition, 24 weeks|Cardiovascular, To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in carotis intima media thickness, pulse wave velocity, 24 hour blood pressure, 24 weeks|Standardised liquid meal test, To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in postprandial glucagon levels, glycaemic excursion, gastric emptying, VAS score for appetite and food preference, 24 weeks|Glycaemic excursions, To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in insulin dose, hypoglycaemic events and glycaemic excursions (time spent in hypo- and hyperglycaemia as measured by CGM), 24 weeks|Quality of life, To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in quality of life and treatment satisfaction, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Steno Diabetes Center Copenhagen | Collaborators: University Hospital, Gentofte, Copenhagen|University of Copenhagen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-06
|
| Completion Date: |
2015-02
|
| Results First Posted: |
|
| Last Update Posted: |
2016-01-27
|
| Locations: |
Steno Diabetes Center, Gentofte, 2820, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01612468
|
