Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | March 2010 |
| End Date: | February 2014 |
| Contact: | Dawn D Smiley, MD |
| Email: | dsmiley@emory.edu |
| Phone: | 404-778-1674 |
Ketosis-Prone Diabetes in African Americans: Predictive Markers, Underlying Mechanisms, and Treatment Outcomes: The Effects of Metformin vs. Sitagliptin on Beta-Cell Preservation in Obese Subjects With Ketosis-Prone Type 2 Diabetes Mellitus
We will plan to study 48 subjects with diabetes and 8 patients without diabetes. The blood
tests from the subjects without diabetes will be helpful in assessing the "normal" response
compared to 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 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.
tests from the subjects without diabetes will be helpful in assessing the "normal" response
compared to 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 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.
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