Hyperglycemia Clinical Trial
Official title:
Ketosis-Prone Diabetes in African Americans: Predictive Markers, Underlying Mechanisms, and Treatment Outcomes: The Effects of Metformin vs. Sitagliptin on Beta-Cell Preservation in Obese Subjects With Ketosis-Prone Type 2 Diabetes Mellitus
The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer
need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called
metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active
medication). Subjects on pills will be followed for 3½ years and undergo blood tests at
specified intervals to assess their ability to make insulin. These studies will allow a
better understanding of the factors that lead to high blood sugar in patients with
ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this
patient population.
Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve
β-cell function, insulin sensitivity, and allow for a longer period of time prior to
encountering an insulin-deficient relapse after discontinuation of insulin therapy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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