A Phase 3 interventional study of Intermittent insulin therapy and Continuous metformin in Type 2 Diabetes, sponsored by Mount Sinai Hospital, Canada. Completed at 1 site in Canada. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Mount Sinai Hospital, Canada · Phase 3, Interventional, and Treatment
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.
In this study, eligible patients with type 2 diabetes will be randomized to either intermittent insulin therapy or continuous metformin therapy, after both arms have first undergone a short course of intensive insulin therapy. The hypothesis under study is whether intermittent insulin therapy can better preserve beta-cell function.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Mount Sinai Hospital, Canada is the lead sponsor of 157 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
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
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
Also known as: Basal insulin glargine and pre-meal insulin lispro
Also known as: Metformin
Baseline-adjusted beta-cell function at 2 years, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
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.
Time frame: 2 years
Baseline-adjusted glycemic control at 2-years.
The secondary outcome of baseline-adjusted glycemic control at 2-years will be assessed by A1c (glycated hemoglobin)
Time frame: 2 years
Achievement of target glycemic control
Achievement of target glycemic control will be assessed by the proportion of participants with A1c \<7.0%
Time frame: 2 years
achievement of glucose tolerance in the non-diabetic range
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.
Time frame: 2 years
achievement of normal glucose tolerance
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.
Time frame: 2 years
insulin sensitivity
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
Time frame: 2 years
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada