Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Pilot Study)
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|ClinicalTrials.gov Identifier: NCT01755468|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Intermittent insulin therapy Drug: Continuous metformin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Pilot Study)|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Continuous metformin
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: Continuous metformin
Other Name: Metformin
Experimental: Intermittent insulin therapy
After a 3-week course of intensive insulin therapy, participants will receive intermittent intensive insulin therapy for 2 weeks every 3 months. 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: Intermittent insulin therapy
Other Name: Basal insulin glargine and pre-meal insulin lispro
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755468
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Ravi Retnakaran, MD||Mount Sinai Hospital, Canada|
|Principal Investigator:||Bernard Zinman, MD||Mount Sinai Hospital, Canada|