Preferred Treatment of Type 1.5 Diabetes

NCT00194896 | Completed Results DMC

• 3 other identifiers: 16707-D496539-188;16707D
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus; autoantibodies; islet proteins; rosiglitazone; glyburide; c-peptide

Outcome Measures

Primary Outcomes (1)

• Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.

  Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.

  36 months

Secondary Outcomes (1)

• Patients Positive for T Cell Responses to Islet Proteins at 36 Months.

  36 months

Study Arms (2)

rosiglitazone

ACTIVE COMPARATOR

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

glyburide

ACTIVE COMPARATOR

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

Interventions

rosiglitazone DRUG

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.

Also known as: Avandia

rosiglitazone

glyburide DRUG

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.

glyburide

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Seattle Institute for Biomedical and Clinical Research: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

DVA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (35)

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  PMID: 23286943 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosiglitazone; Glyburide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonylurea Compounds; Urea; Amides; Sulfones

Limitations and Caveats

Small numbers based on high drop out of participants.

Results Point of Contact

• Title: Jerry P. Palmer, MD
• Organization: University of Washington

jpp@u.washington.edu

206-764-2495

Study Officials

• Jerry P Palmer, MD

  Seattle Institute for Biomedical & Clinical Research, University of Washington, DVA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2000
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 29, 2018
• Results First Posted: August 10, 2011

Record last verified: 2018-03

Locations

US (1)