| Trial ID: | L2986 |
| Source ID: | NCT01270789
|
| Associated Drug: |
Liraglutide
|
| Title: |
LIraglutide and Beta-cell RepAir (LIBRA) Study
|
| Acronym: |
LIBRA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Liraglutide|DRUG: placebo
|
| Outcome Measures: |
Primary: Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2), ISSI-2 is a validated OGTT-derived measure of beta-cell function analogous to the disposition index obtained from the intravenous glucose tolerance test. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve (AUCins) to the area-under-the-glucose curve (AUCgluc) and (ii) insulin sensitivity measured by the Matsuda index., 48-weeks | Secondary: Glycemic Control, * A1c * Fasting glucose, 2 hour glucose, and AUCgluc on OGTT * Proportion of participants with A1c \<7% at study end * Glucose tolerance status at study end (NGT, pre-diabetes, diabetes) * Proportion of participants with fasting glucose in non-diabetic range at study end (ie. \<7.0 mmol/L) * Time to loss of glycemic control, 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: Mount Sinai Hospital, Canada | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
63
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01
|
| Completion Date: |
2014-05
|
| Results First Posted: |
|
| Last Update Posted: |
2014-09-12
|
| Locations: |
Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01270789
|
