Status:
COMPLETED
Pilot Study of the Effect of MN-504 Cobiotic Formulation on the Efficacy and Tolerability of Metformin
Lead Sponsor:
NuMe Health
Collaborating Sponsors:
Pennington Biomedical Research Center
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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.
Detailed Description
Only subjects with known intolerance to metformin will be recruited and enrolled in this study. When a participant qualifies, after signing the consent, they will be asked to complete a questionnaire ...
Eligibility Criteria
Inclusion
- Male or a female with type 2 diabetes
- Known tolerance to metformin
- 18 years of age or older
- Body mass index that is not less than 20 kg/m2
Exclusion
- Not pregnant or breast feeding a baby.
- Not taking chronic medication that has not had a stable dose for 1 month or longer.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01866462
Start Date
May 1 2013
End Date
July 1 2014
Last Update
July 24 2014
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808