NCT01677299

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Elcelyx Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	EFB0027 (metformin delayed release)	Comparison of enteric-coating to assess effect on PK
DRUG	EFB0026 (metformin immediate-release)	Active comparator

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-09-03
• Last updated: 2016-09-20
• Results posted: 2014-06-16

Locations

2 sites across 1 country: United States