| Trial ID: | L3962 |
| Source ID: | NCT02194595
|
| Associated Drug: |
Basal Insulin And Exenatide
|
| Title: |
Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)
|
| Acronym: |
PREVAIL
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Basal insulin and exenatide|DRUG: Basal insulin only|DRUG: Basal insulin and bolus insulin
|
| Outcome Measures: |
Primary: Mean beta-cell function over the 8-week treatment period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2), ISSI-2 is an established measure of beta-cell function. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve to the area-under-the-glucose curve and (ii) insulin sensitivity measured by the Matsuda index. The primary outcome comparison is between the glargine/exenatide and glargine only arms., 8 weeks | Secondary: Baseline-adjusted beta-cell function at 20 weeks, The secondary outcome of baseline-adjusted beta-cell function at 20 weeks will be measured with the Insulin Secretion-Sensitivity Index-2 (ISSI-2), 20 weeks|Baseline-adjusted glycemic control at 20 weeks, The secondary outcome of baseline-adjusted glycemic control at 20 weeks will be assessed by A1c (glycated hemoglobin), 20 weeks|Endothelial function at 8 weeks, Endothelial function will be assessed as the digital endothelial vasomotor function in response to reactive hyperemia using pulse amplitude tonometry, which will be measured by the pulse amplitude response to hyperemia (PAT ratio), 8 weeks|Baseline-adjusted glycemic control at 8 weeks, Baseline-adjusted glycemic control at 8 weeks will be measured by A1c, 8 weeks | Other: Baseline-adjusted insulin sensitivity at 8 weeks, Baseline-adjusted insulin sensitivity at 8 weeks will be measured by Matsuda index, 8 weeks|Baseline-adjusted insulin sensitivity at 20 weeks, Baseline-adjusted insulin sensitivity at 20 weeks will be measured by Matsuda index, 20 weeks
|
| Sponsor/Collaborators: |
Sponsor: Mount Sinai Hospital, Canada | Collaborators: Canadian Institutes of Health Research (CIHR)|University of Toronto
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-09
|
| Completion Date: |
2022-02
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-11
|
| Locations: |
Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02194595
|
