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

Completed · Phase 4 · Has a placebo group

Conditions studied: Ketosis Prone Diabetes, Diabetes Ketoacidosis, Hyperglycemia

In brief

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.

Key facts

Study ID

NCT01099618

Run by

Dawn Smiley MD

People needed

48

Starts

2010-03-01

Expected to finish

2014-08-01

Last updated by the study team

2015-06-18

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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