NCT01866462

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1 type-2-diabetes

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

May 28, 2013

Last Update Submit

July 23, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Metformin Tolerance

    Fecal frequency, fecal consistency, fecal score and incidence of diarrhea will be assessed using the validated King's Stool Chart.

    6 Weeks

Secondary Outcomes (4)

  • Fasting Blood Glucose

    6 weeks

  • GI Symptoms

    6 weeks

  • GI Stool Profile

    6 weeks

  • Weight Loss

    6 weeks

Study Arms (2)

Metformin, NM504

EXPERIMENTAL

metformin 500mg b.i.d. with NM504 b.i.d. for 1 week followed by metformin 500mg t.i.d. with NM504 b.i.d. for 1 week.

Other: NM504

Metformin, Placebo

PLACEBO COMPARATOR

metformin 500mg b.i.d. with Placebo b.i.d. for 1 week followed by metformin 500mg t.i.d. with Placebo b.i.d. for 1 week.

Interventions

NM504OTHER

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.

Also known as: NM-504, NM-504 cobiotic, NM-504 cobiotic formula, NM504 cobiotic, NM504 cobiotic formula
Metformin, NM504

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or a female with type 2 diabetes
  • Known tolerance to metformin
  • years of age or older
  • Body mass index that is not less than 20 kg/m2

You may not qualify if:

  • Not pregnant or breast feeding a baby.
  • Not taking chronic medication that has not had a stable dose for 1 month or longer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

US(1)