Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
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.
Inclusion Criteria:

 1. All newly diagnosed overweight/obese (BMI >/=28 kg/m2) African-American patients with
 new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause
 will be considered for inclusion into the study. The diagnosis of DKA will be
 established by standard criteria (blood glucose > 250 mg/dL, pH < 7.3, HCO3 < 18
 mmol/L, increased anion gap).

 2. The hyperglycemic group will include patients with an admission plasma glucose > 400
 mg/dL but without the presence of metabolic acidosis or ketosis.

 Exclusion Criteria:

 1. significant medical or surgical illness, including but not limited to myocardial
 ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and
 infectious processes;

 2. recognized or suspected endocrine disorders associated with increased insulin
 resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;

 3. bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;

 4. pregnancy,

 5. have an allergy to any component of metformin or sitagliptin.