Type 2 Diabetes MellitusNCT04047537
Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes
A study testing Medical Food Formulation 1 and Medical Food Formulation 2 in people with Type 2 Diabetes Mellitus, run by Pendulum Therapeutics at 1 site in Ireland.
Trial summary
This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Medical Food Formulation 1 and Medical Food Formulation 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteIreland
- Study dates
- 6 Aug 2019to 30 May 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent
- Have type 2 diabetes treated with diet and exercise alone or in combination with metformin
- If treated with metformin, must have been on a stable dose of the drug for a minimum of 3 months with a stable A1c value
- If treated with diet and exercise alone, must have A1c value ≥6.5%
- If treated with diet and exercise + metformin, must have a stable A1c between 7.0% and 8.5% for at least 3 months
- BMI >25 but <45
Show all 10Show fewer
- If female, must meet all the following criteria:
- Not pregnant or breastfeeding
- If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
- Must be able to communicate with the investigator, and understand and comply with protocol requirements
Who cannot join
- Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
- Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
- Subjects using a proton pump inhibitor must be on a consistent dose that will be maintained throughout the study period
- Present use of probiotics/nutritional supplements. (Note: The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed)
- Subjects who have participated in a structured weight-loss program within the past 3 months
- Subjects who have changed body weight ≥3% within the past month
Show all 18Show fewer
- Excess alcohol consumption; with an alcoholic drink defined as 284 ml of beer, lager, stout , 100 ml of wine or 35.5 ml spirits
- Women: More than 11 standard drinks/week
- Men: More than 17 standard drinks/week
- Subjects who have received an experimental drug within 30 days prior to study entry
- Hospitalization for any reason within the 3 months prior to study entry (Same day surgery centre visits/procedures allowed)
- Active GI disease
- History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy
- Cystic fibrosis
- Significant renal Impairment defined as estimated Glomerular Filtration Rate <45 ml/min
- Subjects receiving systemic corticosteroid therapy
- Subjects receiving Immunosuppression therapy
- Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park
Cork
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Metabolic Effects of Two Formulations of a Food Product (WBF-0011) When Administered to Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin
This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.
Read the detailed description
The medical food formulations being tested in this study contain butyrate-producing organisms plus a microbial strain that contributes to the integrity of the colonic mucin barrier. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards using excipients that are also GRAS qualified.
Subjects will receive their randomized formulation twice a day for 12 weeks.The target population will be patients with Type 2 Diabetes who are not treated with anti-diabetic agents or are treated with metformin alone.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Medical Food Formulation 1, Medical Food Formulation 2, Placebo
- 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.
Medical Food Formulation 1Other
WBF-0011
Medical Food Formulation 2Other
WBF-0011 (0.2X concentration)
PlaceboOther
Placebo Capsules identical to those containing Formulation 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Experimental: WBF-0011 | Other | 2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks Receives: Other: Medical Food Formulation 1 |
| Experimental: WBF-0011 (0.2X concentration) | Other | 2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks Receives: Other: Medical Food Formulation 2 |
| Placebo | Other | 2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels
Measured: From Baseline to Week 12
Secondary outcomes (9)
3-hour blood glucose Area Under the Curve (AUC)
as measured by the Continuous Glucose Monitor (CGM) device in clinic during standardized 3-hour Meal Tolerance Test (MTT)
Measured: Baseline to Weeks 2, 6, 9 and 12
3-hour plasma glucose AUC
as measured by laboratory plasma glucose measurements during standardized 3-hour Meal Tolerance Test (MTT)
Measured: Baseline to Weeks 2, 6, 9 and 12
3-hour blood glucose AUC
as measured by the CGM device at home during standardized 3-hour Meal Tolerance Test (MTT)
Measured: Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11.
24-hour CGM
Time in range (70 to 180 mg/dL)/24-hour period
Measured: From Baseline to Week 12
Fasting Lipid Panel
Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Measured: From Baseline to Week 12
Body weight
Change in body weight in kilograms
Measured: From Baseline to Week 12
Adverse Events
Number of participants with adverse events related to therapy
Measured: From Baseline to Week 12
Change from baseline in Laboratory Chemistry Values
Number of Participants With Abnormal Laboratory Values Related to Therapy
Measured: From Baseline to Week 12
Change from baseline in Laboratory Complete Blood count Values
Number of Participants With Abnormal Laboratory Values Related to Therapy
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start6 Aug 2019
- Primary completion15 Apr 2020
- Study completion30 May 2020
Why it stopped: Covid interference
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pendulum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orville Kolterman, MD, Study director, Whole Biome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047537
- Sponsor's protocol ID
- AFCRO-104
- Status last verified
- May 2022
- First submitted
- 26 Jul 2019
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Metabolic Effects of Two Formulations of a Food Product (WBF-0011) When Administered to Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin
- ClinicalTrials.gov ID
- NCT04047537
- Acronym / sponsor ID
- AFCRO-104
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid interference
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pendulum TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 6 Aug 2019 (actual)
- 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.
This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.
Detailed description
The medical food formulations being tested in this study contain butyrate-producing organisms plus a microbial strain that contributes to the integrity of the colonic mucin barrier. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards using excipients that are also GRAS qualified.
Subjects will receive their randomized formulation twice a day for 12 weeks.The target population will be patients with Type 2 Diabetes who are not treated with anti-diabetic agents or are treated with metformin alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: WBF-0011 | Other | Other: Medical Food Formulation 12 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks |
| Experimental: WBF-0011 (0.2X concentration) | Other | Other: Medical Food Formulation 22 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks |
| Placebo | Other | Other: Placebo2 capsules/day (one in the morning and one in the evening), taken with meal for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be able to give written informed consent
- Have type 2 diabetes treated with diet and exercise alone or in combination with metformin
- If treated with metformin, must have been on a stable dose of the drug for a minimum of 3 months with a stable A1c value
- If treated with diet and exercise alone, must have A1c value ≥6.5%
- If treated with diet and exercise + metformin, must have a stable A1c between 7.0% and 8.5% for at least 3 months
Key exclusion criteria (18 listed)
- Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
- Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
- Subjects using a proton pump inhibitor must be on a consistent dose that will be maintained throughout the study period
- Present use of probiotics/nutritional supplements. (Note: The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed)
- Subjects who have participated in a structured weight-loss program within the past 3 months
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 |
|---|---|---|
| Medical Food Formulation 1WBF-0011 | Other | Experimental: WBF-0011 |
| Medical Food Formulation 2WBF-0011 (0.2X concentration) | Other | Experimental: WBF-0011 (0.2X concentration) |
| PlaceboPlacebo Capsules identical to those containing Formulation 1 and 2 | Other | Placebo |
Primary outcome
Hemoglobin A1c
Time frame: From Baseline to Week 12
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels
9 secondary outcomes
3-hour blood glucose Area Under the Curve (AUC)
Time frame: Baseline to Weeks 2, 6, 9 and 12
3-hour plasma glucose AUC
Time frame: Baseline to Weeks 2, 6, 9 and 12
3-hour blood glucose AUC
Time frame: Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11.
24-hour CGM
Time frame: From Baseline to Week 12
Fasting Lipid Panel
Time frame: From Baseline to Week 12
Body weight
Time frame: From Baseline to Week 12
Adverse Events
Time frame: From Baseline to Week 12
Change from baseline in Laboratory Chemistry Values
Time frame: From Baseline to Week 12
Change from baseline in Laboratory Complete Blood count Values
Time frame: From Baseline to Week 12
Results and safety
The study was stopped early (reason given: Covid interference). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Orville Kolterman, MD study director
Whole Biome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Food Formulation 1 and Medical Food Formulation 2 in people with Type 2 Diabetes Mellitus, run by Pendulum Therapeutics at 1 site in Ireland.
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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 6 May 2022. 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 Ireland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid interference). Results are not available in the source record.
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?
Hemoglobin A1c (time frame: From Baseline to Week 12). 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 6 May 2022.