NCT02192424

Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Main Trial)

A Randomized Controlled Trial to Evaluate Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes: REmission Studies Evaluating Type 2 DM - Intermittent Insulin Therapy (RESET-IT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 intermittent intensive insulin therapy is an effective therapeutic strategy that can preserve pancreatic beta-cell function and maintain glycemic control early in the course of type 2 diabetes.

Detailed description

In this study, eligible patients with type 2 diabetes will be randomized to either intermittent insulin therapy or not, on a background of metformin, after first undergoing a short course of intensive insulin therapy. The hypothesis under study is whether intermittent insulin therapy can preserve beta-cell function.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin alone
DRUG	Metformin + Intermittent Insulin Therapy

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-08-01
• Completion: 2020-09-01
• First posted: 2014-07-16
• Last updated: 2020-10-27

Locations

1 site across 1 country: Canada