NCT01099618

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dawn Smiley MD · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ketosis Prone Diabetes
• Diabetes Ketoacidosis
• Hyperglycemia

Interventions

Type	Name	Description
DRUG	metformin	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.
DRUG	placebo	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.
DRUG	Sitagliptin	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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-02-01
• Completion: 2014-08-01
• First posted: 2010-04-07
• Last updated: 2015-06-18
• Results posted: 2015-06-18

Locations

1 site across 1 country: United States