Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Pilot Study)
This trial is active, not recruiting.
|Condition||type 2 diabetes|
|Treatments||intermittent insulin therapy, continuous metformin|
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Baseline-adjusted beta-cell function at 2 years, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
time frame: 2 years
Baseline-adjusted glycemic control at 2-years.
time frame: 2 years
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 = 5 years prior to enrolment 3. Negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies 4. On either no anti-diabetic medication or on metformin monotherapy, with no change in dose/regimen within 4 weeks prior to enrolment 5. A1c at screening between 5.5% and 9.0% inclusive if on metformin, or between 6.0% and 9.5% inclusive if on no oral anti-diabetic medication 6. BMI >/= 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
|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.|
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