CompletedPhase 4

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

United States48 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range19 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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).
✓. 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

✕. significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes;
✕. recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;
✕. bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;
✕. pregnancy,
✕. have an allergy to any component of metformin or sitagliptin.

What they're measuring

Length of Remission

Timeframe: 3 years

Trial details

NCT IDNCT01099618

SponsorDawn Smiley MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2015-05-09

View on ClinicalTrials.gov More Ketosis Prone Diabetes trials