Status:
COMPLETED
Preferred Treatment of Type 1.5 Diabetes
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Seattle Institute for Biomedical and Clinical Research
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-69 years
Phase:
NA
Brief 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 diab...
Detailed Description
Type 1 diabetes and Type 2 diabetes have different underlying pathophysiologic processes. The disease process in classical Type 1 diabetes is an autoimmune destruction of the pancreatic beta cells. In...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00194896
Start Date
February 1 2000
End Date
December 1 2008
Last Update
March 29 2018
Active Locations (1)
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1
DVA Puget Sound Health Care System
Seattle, Washington, United States, 98108