CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 163 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Placebo 0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00357370
NCT00357370Phase 3Completed
CompareCT.gov

A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.

AstraZeneca·interventional·Posted Jul 27, 2006·Updated May 11, 2017

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes. Completed, enrolled 163 participants across 23 sites in 2 countries.

Detailed Summary

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesCanada, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2006
Enrollment StartOct 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.9 years ago

Interventions

Dapagliflozindrug

Tablets, Oral, once daily, up to 12 weeks

Placebodrug

Tablets, Oral, 0 mg, once daily, up to 12 weeks