MedTrace Logo

Assessing the PK and Effect on Glucose and GI Hormone Concentrations of Metformin Delayed-Release in Subjects With T2DM

NCT01677299 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-09-20

Study results available
· View outcomes & findings →

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

Interventions

DRUG

EFB0027 (metformin delayed release)

Comparison of enteric-coating to assess effect on PK

DRUG

EFB0026 (metformin immediate-release)

Active comparator

Sponsors & Collaborators

  • Elcelyx Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677299 on ClinicalTrials.gov