Status:
COMPLETED
Beta-Cell Function and Sitagliptin Trial (BEST)
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
Type 2 diabetes mellitus (T2DM) 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 in...
Detailed Description
Medications currently used in the treatment of T2DM have not been shown to modify the progressive decline in beta-cell function that occurs over time. Recent evidence, however, suggests that a new cla...
Eligibility Criteria
Inclusion
- Men and women between the ages of 30 and 75 inclusive
- Physician-diagnosed type 2 diabetes on 0-2 oral hypoglycemic agents
- Negative for anti-glutamic acid decarboxylase (anti-GAD\_ antibodies (to rule out Latent Autoimmune Diabetes of Adults (LADA)
- A1c at screening between 6.5% and 9% inclusive if on no oral hypoglycemic agents or 6.0% and 9.0% inclusive if on 1-2 oral hypoglycemic agents
Exclusion
- Current insulin therapy
- Type 1 diabetes or secondary forms of diabetes
- Any major illness with a life expectancy of \< 5 years or that may interfere with the patient's participation in the study
- Involvement in any other study requiring drug therapy
- Renal dysfunction as evidenced by serum creatinine \>/= 136 umol/L for males or \>/= 124 umol/L for females or abnormal creatinine clearance (\< 60 ml/min by Modification of Diet in Renal Disease (MDRD) formula)
- Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \> 2.5 times the upper limit of normal
- Excessive alcohol consumption, defined as \> 14 alcoholic drinks per week for males and \> 9 alcoholic drinks per week for females
- Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study. Reliable contraception includes: birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide. Any women who miss a menstrual period or think that they may be pregnant must have a pregnancy test as soon as possible
- History of serious arrhythmia or atrioventricular block on baseline electrocardiogram
- Uncontrolled hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg)
- Unwillingness to undergo multiple daily insulin injection therapy for 4 weeks
- Unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00420511
Start Date
January 1 2007
End Date
September 1 2009
Last Update
January 2 2012
Active Locations (1)
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1
Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada, M5T 3L9