Clinical Trial: Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ketosis-Prone Diabetes in African Americans: Predictive Markers, Underlying Mechanisms, and Treatment Outcomes: The Effects of Metformin vs. Sitagliptin on Beta-Cell Prese

Brief 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.


Detailed Summary:
Sponsor: Dawn Smiley MD

Current Primary Outcome: Length of Remission [ Time Frame: 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.


Original Primary Outcome: Predictive of short- and long-term near-normoglycemic remission [ Time Frame: 3 years ]

Determine what clinical, metabolic and immunogentic markers, alone or in combination, are predictive of short- and long-term near-normoglycemic remission. Clinical features (weight, BMI, age in years, sex, FHx of diabetes), metabolic (bicarbonate, ph, glucose level, BOHB level), immunogenetic markers (GAD, ICA)


Current Secondary Outcome:

Original Secondary Outcome:

  • Molecular markers in skeletal muscle [ Time Frame: 3 years ]
    Correlate specific molecular markers in skeletal muscle with patient outcome, β-cell function, and insulin sensitivity. Western blots will be performed on the muscle samples. OGTT will be done to follow beta-cell function and a frequently sampled IVGTT will be done to assess insulin sensitivity
  • Length of time in remission [ Time Frame: 3 years ]
    Those patients that are able to discontinue insulin therapy at or <12 weeks will be randomized to 1 of 3 study arms. They will be followed for the duration of the study.


Information By: Emory University

Dates:
Date Received: March 15, 2010
Date Started: March 2010
Date Completion:
Last Updated: May 30, 2015
Last Verified: May 2014