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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
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.
Details
| Lead sponsor | Dawn Smiley MD |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | 2010-03 |
| Completion | 2014-08 |
Conditions
- Ketosis Prone Diabetes
- Diabetes Ketoacidosis
- Hyperglycemia
Interventions
- metformin
- placebo
- Sitagliptin
Primary outcomes
- Length of Remission — 3 years
For those patients that are able to discontinue insulin therapy at or \<12 weeks, how long were they able to well controlled with an A1c \<7% on the agent that they were randomized to.
Countries
United States