Preferred Treatment of Type 1.5 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Seattle Institute for Biomedical and Clinical Research
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194896
First received: September 14, 2005
Last updated: August 16, 2011
Last verified: August 2011
  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:


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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00194896

Locations
United States, Washington
DVA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
Seattle Institute for Biomedical and Clinical Research
GlaxoSmithKline
Investigators
Principal Investigator: Jerry P Palmer, MD Seattle Institute for Biomedical & Clinical Research, University of Washington, DVA Puget Sound Health Care System
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by University of Washington:
type 2 diabetes mellitus
autoantibodies
islet proteins
rosiglitazone
glyburide
c-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014