At a glance
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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
In Brief
A Phase 4 clinical trial evaluating metformin, placebo, and 1 other intervention for Ketosis Prone Diabetes and 2 related conditions. Completed, enrolled 48 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG \< 130mg/dL and A1c \<7%) during the 3-year follow-up period.
The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG \< 130mg/dL and A1c \<7%) during the 3-year follow-up period.
The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG \< 130mg/dL and A1c \<7%) during the 3-year follow-up period.