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Ketosis-Prone Diabetes Mellitus (KPDM): Pioglitazone Versus Sitagliptin Treatment

2014-08-27 03:14:45 | BioPortfolio

Summary

We will plan to study 48 subjects with diabetes and 8 patients without diabetes. The blood tests from the subjects without diabetes will be helpful in assessing the "normal" response compared to 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 pioglitazone, 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 KPDM and direct the best diabetes treatment for this patient population.

Hypothesis: Pioglitazone 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Ketosis Prone Diabetes

Intervention

pioglitazone, Sitagliptin, placebo

Location

Grady Memorial Hospital
Atlanta
Georgia
United States
30303

Status

Recruiting

Source

Emory University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:45-0400

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