Type 2 DiabetesEarly Phase 1NCT01866462
Pilot Study of the Effect of MN-504 Cobiotic Formulation on the Efficacy and Tolerability of Metformin
A Early Phase 1 study testing NM504 in people with Type 2 Diabetes, run by NuMe Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- NM504
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not pregnant or breast feeding a baby.
- Not taking chronic medication that has not had a stable dose for 1 month or longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Pilot Study of the Effect of NM-504 Cobiotic Formulation on the Efficacy and Tolerability of Metformin in Patients With Metformin Intolerance
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.
Read the 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
- Being tested
- NM504
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM504Other
Also called NM-504, NM-504 cobiotic, NM-504 cobiotic formula, NM504 cobiotic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin Tolerance
Fecal frequency, fecal consistency, fecal score and incidence of diarrhea will be assessed using the validated King's Stool Chart.
Measured: 6 Weeks
Secondary outcomes (4)
Fasting Blood Glucose
Fasting blood glucose will be measured by finger stick daily.
Measured: 6 weeks
GI Symptoms
Other possible GI symptoms such as sensations of bloating and flatulence will be measured with a questionnaire adapted from the validated Irritable Bowel Syndrome Global Improvement Scale.
Measured: 6 weeks
GI Stool Profile
Stool will be collected at baseline, after the initial 2 week treatment, at the end of the washout period, and at the completion of the study. The complete stool GI function profile assessed by Genova Diagnostics will be performed.
Measured: 6 weeks
Weight Loss
Body weight will be measured at each clinic visit.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuMe Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866462
- Sponsor's protocol ID
- ProCo Metformin
- Status last verified
- Jul 2014
- First submitted
- 28 May 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of NM-504 Cobiotic Formulation on the Efficacy and Tolerability of Metformin in Patients With Metformin Intolerance
- ClinicalTrials.gov ID
- NCT01866462
- Acronym / sponsor ID
- ProCo Metformin
- Conditions
- Type 2 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NuMe HealthIndustry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin, NM504 | Experimental | Other: NM504metformin 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not pregnant or breast feeding a baby.
- Not taking chronic medication that has not had a stable dose for 1 month or longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NM504Also: NM-504, NM-504 cobiotic, NM-504 cobiotic formula, NM504 cobioticNM504 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 | Metformin, NM504 |
Primary outcome
Metformin Tolerance
Time frame: 6 Weeks
Fecal frequency, fecal consistency, fecal score and incidence of diarrhea will be assessed using the validated King's Stool Chart.
4 secondary outcomes
Fasting Blood Glucose
Time frame: 6 weeks
GI Symptoms
Time frame: 6 weeks
GI Stool Profile
Time frame: 6 weeks
Weight Loss
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NM504 in people with Type 2 Diabetes, run by NuMe Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metformin Tolerance (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.