Status:
COMPLETED
Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Main Trial)
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief Summary
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 (...
Detailed Description
In this study, eligible patients with type 2 diabetes will be randomized to either intermittent insulin therapy or not, on a background of metformin, after first undergoing a short course of intensive...
Eligibility Criteria
Inclusion
- Men and women between the ages of 30 and 80 years inclusive
- T2DM diagnosed by a physician \</= 5 years prior to enrolment
- Negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies
- On either no anti-diabetic medication or on metformin monotherapy, with no change in dose/regimen within 4 weeks prior to enrolment
- 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
- BMI \>/= 23 kg/m2
- Negative pregnancy test at recruitment for all women with childbearing potential
Exclusion
- Current anti-diabetic treatment with insulin, sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1) agonist or dipeptidyl peptidase-4 inhibitor
- Type 1 diabetes or secondary forms of diabetes
- History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
- Any major illness with a life expectancy of \<5 years
- Hypersensitivity to insulin, metformin or the formulations of these products
- Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR) \<50 ml/min
- Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, previous liver transplant) or transaminases \>2.5 X upper limit of normal
- History of congestive heart failure
- Excessive alcohol consumption, defined as \>14 alcoholic drinks per week for males and \>9 alcoholic drinks per week for females
- Unwillingness to administer insulin therapy or perform capillary blood glucose monitoring at least 4 times per day while receiving IIT
- 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.
- Non-adherence to the induction phase or any factor likely to limit adherence to the study protocol, in the opinion of the investigator
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02192424
Start Date
July 1 2014
End Date
September 1 2020
Last Update
October 27 2020
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5