Phase 4
N=48
Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
Ketosis Prone Diabetes · Diabetes Ketoacidosis · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT01099618 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Length of Remission — 472; 589; 111 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- metformin (Drug); placebo (Drug); Sitagliptin (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Dawn Smiley MD
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Remission |
472; 589; 111 | — |
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
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01099618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.