Overview

Preferred Treatment of Type 1.5 Diabetes

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborators:
GlaxoSmithKline
Seattle Institute for Biomedical and Clinical Research
Treatments:
Glyburide
Rosiglitazone
Criteria
Inclusion Criteria:

- Age at onset of diabetes - 35-69 years old.

- No history of ketonuria or ketoacidosis.

- Not requiring insulin to achieve glycemic control.

- Not receiving more than two oral hypoglycemic agents.

- Not taking a thiazolidinedione agent.

- HbA1c in established patients (on an oral hypoglycemia agent for over 4 months) of
greater than 6% and under 10%.

- Fasting c-peptide greater than or equal to 0.8 ng/ml.

- Women must be either post-menopausal or on adequate birth control (i.e. oral
contraceptives, tubal ligation, hysterectomy, condoms, or diaphragm) or use
abstinence.

Exclusion Criteria:

- Patients with history of chronic pancreatitis or other secondary causes of diabetes.

- Patients receiving systemic corticosteroids.

- Patients with severe systemic illness (e.g. recent MI, CHF or cerebral vascular
disease).

- Creatinine greater than 1.4 or liver enzymes greater than 2 times the upper limits of
normal.

- Not able to adhere to the protocol.