Pilot Study of the Effect of MN-504 Cobiotic Formulation on the Efficacy and Tolerability of Metformin
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): NM504
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): NM-504; NM-504 cobiotic; NM-504 cobiotic formula; NM504 cobiotic; NM504 cobiotic formula
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention