At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Parallel Design Trial to Compare the Efficacy of a Sitagliptin-based Metabolic Intervention Versus Standard Diabetes Therapy in Inducing Remission of Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating insulin glargine, sitagliptin/metformin, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 102 participants across 6 sites.
Detailed Summary
The purpose of the study is to determine whether in patients with early type 2 diabetes,a short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
Study Details
Timeline
Interventions
Dose is titrated to achieve fasting normoglycemia
Dose is titrated to 50/1000 mg bid or maximal tolerated dose
Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving