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Pilot Study of the Effect of MN-504 Cobiotic Formulation on the Efficacy and Tolerability of Metformin

NCT01866462 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-24

No results posted yet for this study

Summary

The purpose of the study is to determine if NM504 will prevent GI side effects that are associated with using metformin for the treatment of diabetes.

Conditions

Interventions

OTHER

NM504

NM504 is a medical food designed to shift the dysbiota reported in type 2 diabetes. The placebo is carboxymethylcellulose prepared to look, taste and mix like NM504.

Sponsors & Collaborators

  • Pennington Biomedical Research Center

    collaborator OTHER

  • NuMe Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

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 NCT01866462 on ClinicalTrials.gov