Preferred Treatment of Type 1.5 Diabetes (NCT00194896) | Clinical Trial Compass
CompletedNot Applicable
Preferred Treatment of Type 1.5 Diabetes
United States64 participantsStarted 2000-02
Plain-language 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.
Who can participate
Age range
35 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.