This trial is active, not recruiting.

Condition type 2 diabetes
Treatments intermittent insulin therapy, continuous metformin
Phase phase 3
Sponsor Mount Sinai Hospital, Canada
Collaborator Canadian Institutes of Health Research (CIHR)
Start date April 2013
End date December 2017
Trial size 24 participants
Trial identifier NCT01755468, 12-0263-A Pilot


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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).
continuous metformin 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
intermittent insulin therapy Basal insulin glargine and pre-meal insulin lispro

Primary Outcomes

Baseline-adjusted beta-cell function at 2 years, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
time frame: 2 years

Secondary Outcomes

Baseline-adjusted glycemic control at 2-years.
time frame: 2 years

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

Inclusion Criteria: 1. Men and women between the ages of 30 and 80 years inclusive 2. T2DM diagnosed by a physician /= 23 kg/m2 7. Negative pregnancy test at recruitment for all women with childbearing potential Exclusion Criteria: 1. Current anti-diabetic treatment with insulin, sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, GLP-1 agonist or dipeptidyl peptidase-4 inhibitor 2. Type 1 diabetes or secondary forms of diabetes 3. History of hypoglycemia unawareness or severe hypoglycemia requiring assistance 4. Any major illness with a life expectancy of <5 years 5. Hypersensitivity to insulin, metformin or the formulations of these products 6. Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR) <50 ml/min 7. Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, previous liver transplant) or transaminases >2.5 X upper limit of normal 8. History of congestive heart failure 9. Excessive alcohol consumption, defined as >14 alcoholic drinks per week for males and >9 alcoholic drinks per week for females 10. Unwillingness to administer insulin therapy or perform capillary blood glucose monitoring at least 4 times per day while receiving IIT 11. Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide. 12. Non-adherence to the induction phase or any factor likely to limit adherence to the study protocol, in the opinion of the investigator

Additional Information

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)
Principal investigator Ravi Retnakaran, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada.