At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
EFB0027 (metformin delayed release) +1 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 Randomized, Crossover Study Assessing the Effects of pH 6.5 Enteric Coating of Metformin HCl Tablets on Pharmacokinetics and Changes in Circulating Glucose and Gastrointestinal Hormone Concentrations in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating EFB0027 (metformin delayed release) and EFB0026 (metformin immediate-release) for Type 2 Diabetes Mellitus. Completed, enrolled 24 participants across 2 sites.
Detailed Summary
This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes mellitus. In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
Primary CompletionSep 2012
First PostedSep 2012
TodayJul 2026
First PostedSep 3, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.8 years ago
Interventions
EFB0027 (metformin delayed release)drug
Comparison of enteric-coating to assess effect on PK
EFB0026 (metformin immediate-release)drug
Active comparator