| Trial ID: | L3119 |
| Source ID: | NCT01722266
|
| Associated Drug: |
Liraglutide
|
| Title: |
Liraglutide in the Treatment of Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01722266/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Liraglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Mean Weekly Glucose Concentrations, The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups., 12 Weeks | Secondary: Change in HbA1c, Change from baseline (week 0) in HbA1c at 12 weeks after treatment, 12 Weeks|Change in Body Weight From Baseline, Change in Body weight in Kg from baseline after 12 weeks of treatment, 12 weeks|Change in Total Insulin Dose From Baseline, Total daily insulin dose = Basal insulin dose plus bolus insulin dose. Change from baseline in Total daily insulin dose at 12 weeks from treatment., 12 weeks|Change in the Area Under Curve (AUC) of Glucose Following the Meal, Change in the Area Under Curve (AUC0h-5h) of glucose concentration measured following meal challenge of up to 5hrs performed at baseline (week 0) at 12 weeks following treatment., 12 weeks|Change in Carbohydrate Intake, Change from baseline (0 week) in Daily Carbohydrate intake (in grams) at 12 weeks after treatment., 12 weeks|Change in Glucagon Concentrations, change from baseline (week 0) in glucagon concentrations following 12 weeks of treatment, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University at Buffalo | Collaborators: Novo Nordisk A/S
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-11-01
|
| Completion Date: |
2014-12-01
|
| Results First Posted: |
2015-03-13
|
| Last Update Posted: |
2024-01-05
|
| Locations: |
Diabetes-Endocrinology Center of Western NY, Williamsville, New York, 14221, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01722266
|
