Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

NCT02194595 · Completed

Last updated 2026-05-28

This clinical trial tested whether the medication exenatide, combined with insulin, could help preserve beta-cell function in adults with type 2 diabetes over an 8-week treatment period.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 105 people

Who can join Ages 30–80 · all sexes

Timeline Started 2014-09 · est. completion 2022-02

Where 1 site · Canada

What this study is testing ClinicalTrials.gov NCT02194595 ↗

Description as written by the study sponsor.

Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a randomized controlled trial to determine whether combining basal insulin with a new medication called exenatide is a therapeutic strategy that can preserve beta-cell function early in the course of type 2 diabetes.

Treatments tested

Basal insulin and exenatide also known as Basal insulin glargine, Exenatide Drug
Basal insulin only also known as Basal insulin glargine Drug
Basal insulin and bolus insulin also known as Basal insulin glargine, Pre-meal insulin lispro Drug

Main thing measured	Mean beta-cell function over the 8-week treatment period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Sponsor	Mount Sinai Hospital, Canada
Conditions studied	Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02194595 ↗