| Trial ID: | L2748 |
| Source ID: | NCT01779362
|
| Associated Drug: |
Metformin
|
| Title: |
RISE Adult Medication Study
|
| Acronym: |
RISE Adult
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01779362/results
|
| Conditions: |
Prediabetes|Type 2 Diabetes
|
| Interventions: |
DRUG: Metformin|DRUG: Liraglutide|DRUG: Glargine|DRUG: Placebo
|
| Outcome Measures: |
Primary: ß-cell Response Measured by Hyperglycemic Clamp, Clamp measures of ß-cell response, co-primary outcomes, 3-months after medication washout (Month 15)|Insulin Sensitivity, M/I, Clamp measure of insulin sensitivity, 3-months after a medication washout | Secondary: ACPRg, First phase response from the hyperglycemic clamp, 3-months after a medication washout|ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12, Participants had 12-months of active therapy. Secondary results at the end of active intervention., Secondary analysis was on all participants with a Month 12 visit.
|
| Sponsor/Collaborators: |
Sponsor: RISE Study Group | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
267
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-04
|
| Completion Date: |
2019-08
|
| Results First Posted: |
2023-05-11
|
| Last Update Posted: |
2023-05-11
|
| Locations: |
Jesse Brown VA Medical Center, Chicago, Illinois, 60612, United States|University of Chicago, Chicago, Illinois, 60637, United States|Indiana University, Indianapolis, Indiana, 46202, United States|VA Puget Sound Health Care System, Seattle, Washington, 98108, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01779362
|
