Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Main Trial) (RESET-IT)
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|ClinicalTrials.gov Identifier: NCT02192424|
Recruitment Status : Recruiting
First Posted : July 16, 2014
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Metformin alone Drug: Metformin + Intermittent Insulin Therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: Metformin alone
After a 3-week course of intensive insulin therapy, participants will be treated with ongoing metformin monotherapy. Metformin will be initiated at 500mg twice a day for the first 2 weeks, before progressing to 1000mg twice a day for the duration of the trial (24 months).
Drug: Metformin alone
Other Name: metformin
Experimental: Metformin + Intermittent Insulin Therapy
After a 3-week course of intensive insulin therapy, participants will be treated with ongoing metformin monotherapy, initiated at 500mg twice a day for the first 2 weeks, before progressing to 1000mg twice a day for the duration of the trial (24 months). Participants will stop their metformin for 2 weeks every 3 months, during which time they will receive intermittent intensive insulin therapy for 2 weeks. The 2-week course of insulin therapy will be repeated at 3-, 6-, 9-, 12-, 15-,18- and 21-months, with final outcome measurement performed at 24-months.
Drug: Metformin + Intermittent Insulin Therapy
- Baseline-adjusted beta-cell function at 2 years, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2). [ Time Frame: 2 years ]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.
- Baseline-adjusted glycemic control at 2-years. [ Time Frame: 2 years ]The secondary outcome of baseline-adjusted glycemic control at 2-years will be assessed by A1c (glycated hemoglobin)
- Achievement of target glycemic control [ Time Frame: 2 years ]Achievement of target glycemic control will be assessed by the proportion of participants with A1c <7.0%
- achievement of glucose tolerance in the non-diabetic range [ Time Frame: 2 years ]The proportion of participants with glucose tolerance in the non-diabetic range will be determined on oral glucose tolerance test (OGTT) and defined based on current Canadian Diabetes Association classifications for glucose tolerance status on OGTT.
- achievement of normal glucose tolerance [ Time Frame: 2 years ]The proportion of participants with normal glucose tolerance will be determined on oral glucose tolerance test (OGTT) and defined based on current Canadian Diabetes Association classifications for glucose tolerance status on OGTT.
- insulin sensitivity [ Time Frame: 2 years ]Insulin sensitivity will be measured by Matsuda index, a clamp-validated measure of whole-body insulin sensitivity that can be obtained from the oral glucose tolerance test
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192424
|Contact: Ravi Retnakaran, MD||416-586-4800 ext firstname.lastname@example.org|
|Contact: Bernard Zinman, MDemail@example.com|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator: Ravi Retnakaran, MD|
|Principal Investigator:||Ravi Retnakaran, MD||Mount Sinai Hospital, New York|