CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
rosiglitazone +1 moredrug
Likely dose
Rosiglitazone 4 mg orally once daily, increased to twice daily if glycemic control inadequate; or glyburide 2.5-10 mg orally twice dailyAI-extracted
Key inclusion· 6
  • Age 35-69 years at diabetes onset
  • No history of ketonuria or diabetic ketoacidosis
  • Not requiring insulin for glycemic control
  • Currently on ≤2 oral hypoglycemic agents
Key exclusion· 4
  • History of chronic pancreatitis or other secondary diabetes causes
  • Receiving systemic corticosteroids
  • Severe systemic illness (recent MI, CHF, cerebrovascular disease)
  • Creatinine >1.4 mg/dL or liver enzymes >2× upper limit of normal

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194896
NCT00194896N/ACompleted

Rosiglitazone Intervention Study in Patients With Type 1.5 Diabetes

University of Washington·interventional·Posted Sep 19, 2005·Updated Mar 29, 2018

In Brief

A clinical study evaluating rosiglitazone and glyburide for Type 2 Diabetes Mellitus. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartFeb 1, 2000
Primary CompletionSep 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 20.8 years ago

Interventions

rosiglitazonedrug

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.

glyburidedrug

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.