CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 768 enrolled
Drug / intervention
Saxagliptin +5 moredrug
Likely dose
Saxagliptin 2.5 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/NCT00313313
NCT00313313Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone

AstraZeneca·interventional·Posted Apr 12, 2006·Updated May 4, 2015

In Brief

A Phase 3 clinical trial evaluating Saxagliptin, Glyburide, and 2 other interventions for Diabetes. Completed, enrolled 768 participants across 115 sites in 13 countries.

Detailed Summary

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesArgentina, Brazil, Hong Kong, Israel, Mexico, Peru, Philippines, Puerto Rico, Singapore, South Africa, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2006
Enrollment StartApr 1, 2006
Primary CompletionSep 1, 2007
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.2 years ago

Interventions

Saxagliptindrug

Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])

Saxagliptindrug

Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).

Glyburidedrug

Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

Placebodrug

Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

Glyburidedrug

Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)

Metformindrug

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)