Phase 1/2Completed
Assessing the PK and Effect on Glucose and GI Hormone Concentrations of Metformin Delayed-Release in Subjects With T2DM
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
- Sponsor
- Elcelyx Therapeutics, Inc. (Industry)
- Enrolment
- 24 enrolled
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- EFB0027 (metformin delayed release); EFB0026 (metformin immediate-release)
- Ages
- adults, older adults
- Registry
- NCT01677299
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area Under the Curve (0-t) of Plasma Metformin
- Change in Fasting Plasma Glucose
- Within Treatment Comparison Based on Ratios of AUCs of GLP-1
- Within Treatment Comparison Based on Ratios of AUCs of PYY
History
Last registry update
Results first posted
Primary completion
Registered
Started