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

NCT ID: NCT01866462

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-07-31

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 about medical history which will be reviewed with the coordinator. Their height, weight, and blood pressure will be measured, and their medications will be reviewed. They will be taught how to measure their fasting blood glucose by a finger stick. They will be given metformin and asked to take a 500mg tablet twice day before breakfast and dinner starting the next day with breakfast. They will be given doses of NM504 or a placebo in a pouch to be mixed with 6 ounces of water before breakfast and dinner as a smoothie drink starting before breakfast the next day. Before consuming the first smoothie each day and before eating any food each day they will be asked to record their fasting finger stick blood glucose and complete the questionnaire about their bowel habits. The study takes place in two-week segments with a two week washout in between. They will receive metformin in both periods, but they will receive NM504 during one 2-week segment and a placebo smoothie during the other two-week segment. Five subjects will receive NM504 and 5 subjects will be assigned placebo during the initial 2 weeks. The treatment sequence will be randomly assigned. After the 2 week washout period the subjects will cross over to either placebo or NM504.

Phone Visit 1: week 1 subjects will receive a call from the coordinator to see how they are tolerating the metformin and the smoothies. An increase in metformin dose to 500mg 3 times a day may or may not happen.

Clinic Visit 2: week 2, Subjects will bring bottle of metformin and empty packages of smoothie powder to the visit along with logs of their daily fasting finger stick blood glucose and their daily bowel questionnaires. Their body weight weight will be measured.

Clinic Visit 3: week 4, subjects will be asked about their metformin tolerance and body weight will be measured. They will be given metformin and asked to take a 500 mg pill twice a day before breakfast and dinner starting the next day before breakfast. Before consuming the first smoothie each day, and before eating any food each day, subjects will be asked to record a fasting finger stick blood glucose and complete the questionnaire about bowel habits.

Phone Visit 2: week 5 subjects will be asked about their tolerance to metformin and the smoothies. They may or may not be asked to increase their 500mg dose of metformin from 2 times a day to 3 times a day.

Clinic Visit 4: week 6, Subjects will bring the bottle of metformin and the empty packages of the smoothie powder to the visit along with the logs of daily fasting finger stick blood glucose and daily bowel questionnaires. Their body weight will be measured at the end of the study.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Metformin, NM504

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.

Group Type: EXPERIMENTAL

NM504

Intervention Type: OTHER

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.

Metformin, Placebo

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.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

NM-504; NM-504 cobiotic; NM-504 cobiotic formula; NM504 cobiotic; NM504 cobiotic formula

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

NuMe Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

ProCo Metformin

Identifier Type: -

Identifier Source: org_study_id