At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 957 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Saxagliptin 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.
A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy
In Brief
A Phase 4 clinical trial evaluating Saxagliptin and Glimepiride for Type 2 Diabetes Mellitus. Completed, enrolled 957 participants across 131 sites in 13 countries.
Detailed Summary
This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesAustria, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Mexico, Norway, Spain, Sweden, United Kingdom
CollaboratorsBristol-Myers Squibb
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedNov 2009
Primary CompletionJun 2012
TodayJul 2026
First PostedNov 3, 2009
Enrollment StartOct 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.7 years ago
Interventions
Saxagliptindrug
5 mg, oral tablet, once daily
Glimepiridedrug
1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily