At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
PF-04937319 once-daily +2 moredrug
Likely dose
PF-04937319 once-daily 300 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 Phase 1b, Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of Pf-04937319 In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
In Brief
A Phase 1 clinical trial evaluating PF-04937319 once-daily, PF-04937319 split-dose, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 33 participants across 8 sites.
Detailed Summary
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionMar 2014
TodayJul 2026
First PostedSep 2, 2013
Enrollment StartOct 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.8 years ago
Interventions
PF-04937319 once-dailydrug
Tablets, 300 mg once-daily with breakfast, 14-days
PF-04937319 split-dosedrug
tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
Sitagliptin once-dailydrug
tablets, 100 mg once-daily with breakfast, 14-days