Preferred Treatment of Type 1.5 Diabetes - Full Text View

Sponsor:	University of Washington
Collaborators:	Seattle Institute for Biomedical and Clinical Research GlaxoSmithKline
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00194896

Sponsor:

University of Washington

Collaborators:

Seattle Institute for Biomedical and Clinical Research
GlaxoSmithKline

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00194896

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: rosiglitazone Drug: glyburide

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Rosiglitazone Intervention Study in Patients With Type 1.5 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glyburide Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.

Secondary Outcome Measures:

Patients Positive for T Cell Responses to Islet Proteins at 36 Months. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Number of participants positive for T cell reactivity to islet proteins at 36 months.

Enrollment:	64
Study Start Date:	February 2000
Study Completion Date:	December 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: rosiglitazone Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved.	Drug: rosiglitazone Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years. Other Name: Avandia
Active Comparator: glyburide Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control.	Drug: glyburide Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was increased by 2.5 mg in the evening up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Study drug was taken up to 3 years.

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Eligibility

Ages Eligible for Study:	35 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Responsible Party:	Jerry P. Palmer, MD, Professor, Principal Investigator, University of Washington, Seattle Institute for Biomedical & Clinical Research
ClinicalTrials.gov Identifier:	NCT00194896 History of Changes
Other Study ID Numbers:	16707-D, 496539-188;, 16707D
Study First Received:	September 14, 2005
Results First Received:	February 22, 2011
Last Updated:	August 16, 2011
Health Authority:	United States: Institutional Review Board

United States, Washington
DVA Puget Sound Health Care System
Seattle, Washington, United States, 98108