drugset / Trial / NCT01755468

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

NCT01755468

RandomizedParallel-groupOpen-labelTreatment

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 pilot 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.

Timeline

Start
2013-04
Primary completion
2017-10
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Lispro Protein / enzyme biologic
Comparator Metformin Small molecule 1000 mg
Subject insulin glargine Protein / enzyme biologic