N/A
Completed N=64
Preferred Treatment of Type 1.5 Diabetes
Source: ClinicalTrials.gov NCT00194896 ↗Enrolled (actual)
64
Serious AEs
9.4%
Results posted
Aug 2011
Primary outcomePrimary: Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months. — -0.4; -1.4; 0.1; 0.3 ng per ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months. |
-0.4; -1.4; 0.1; 0.3; -0.6; -2.8 | — |
| SECONDARY Patients Positive for T Cell Responses to Islet Proteins at 36 Months. |
1; 2; 2; 3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00194896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.