Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
Condition: Ketosis Prone Diabetes; Diabetes Ketoacidosis; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia; Ketosis; Diabetes Mellitus, Type 1
Intervention: metformin; placebo; Sitagliptin
Intervention description: 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.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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.