At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 461 enrolled
Drug / intervention
Saxagliptin +5 moredrug
Likely dose
Not stated in 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.
A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Dapagliflozin, and 4 other interventions for Type 2 Diabetes. Completed, enrolled 461 participants across 79 sites in 6 countries.
Detailed Summary
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesHungary, Mexico, Poland, Romania, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedNov 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedNov 6, 2014
Enrollment StartSep 9, 2014
Primary CompletionSep 20, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.7 years ago
Interventions
Saxagliptindrug
administered orally once daily
Dapagliflozindrug
administered orally once daily
Sitagliptindrug
administered orally once daily
Placebo matching with Saxagliptindrug
administered orally once daily
Placebo matching with Dapagliflozindrug
administered orally once daily
Placebo matching with Sitagliptindrug
administered orally once daily