Status:
COMPLETED
Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Toronto
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 open-label, parallel-arm randomized controlled trial, adults with T2DM of ≤7 years duration on 0-2 anti-diabetic medications will be randomized to 8-weeks treatment with either (i) basal insul...
Eligibility Criteria
Inclusion
- Men and women between the ages of 30 and 80 years inclusive
- T2DM diagnosed by a physician ≤7 years prior to enrolment
- On 0-2 anti-diabetic medications, with no change in dose/regimen in the preceding 4 weeks
- A1c at screening between 5.5% and 9.0% inclusive if on anti-diabetic medications, 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 or a glucagon-like peptide-1 (GLP-1) agonist
- Type 1 diabetes or secondary forms of diabetes
- History of hypoglycemia unawareness or severe hypoglycemia requiring assistance
- Hypersensitivity to insulin, exenatide, or the formulations of these products
- Renal dysfunction as evidenced by estimated glomerular filtration rate (eGFR)\<30 ml/min by Modification of Diet in Renal Disease (MDRD) formula
- History of pancreatitis
- Family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (MTC)
- Personal history of non-familial medullary thyroid carcinoma (MTC)
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
- Unwillingness to perform capillary glucose monitoring at least 4 times a day during treatment
- 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.
- Any factor likely to limit adherence to the protocol, in the opinion of investigator
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02194595
Start Date
September 1 2014
End Date
February 1 2022
Last Update
April 11 2022
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5