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Type 2 Diabetes MellitusNCT03893422

Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes

A study testing WB-010 and WB-011 in people with Type 2 Diabetes Mellitus, run by Pendulum Therapeutics at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were safety, glucose AUC during meal tolerance test and C reactive protein (CRP).. 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?
WB-010 and WB-011
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
5 sitesUnited States
Study dates
22 Oct 2017to 14 Sep 2018
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

  • Type 2 diabetes treated with diet and exercise alone or in combination with metformin and/or sulfonylurea
  • If treated with metformin and/or sulfonylurea, must have been on a stable dose of the drug(s) for a minimum of 3 months with a stable A1c value
  • If treated with diet and exercise alone, must have one of the following:
  • Documented fasting plasma glucose >126 mg/dL
  • A1c value ≥6.8%
  • If treated with diet and exercise + metformin and/or sulfonylurea, must have a stable A1c between 6.8% and 11.0% for 3 months prior study entry
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  • BMI >25 but <45 and weight stable within +/- 5% over past 3 months
  • If female, must meet all the following criteria:
  • Not pregnant or breastfeeding
  • If of childbearing potential (including peri-menopausal women with menstruation during past year) must practice and be willing to continue appropriate birth control during the entire duration of the study
  • Have a home freezer available for immediate freezing of stool samples
  • Able to read, understand, and sign the informed consent form (ICF) and HIPAA authorization when applicable,
  • Able to communicate with the investigator, and understand and comply with protocol requirements

Who cannot join

  • Use of antibiotic, antifungal, antiparasitic, or antiviral therapy within 30 days prior to study entry
  • Planned use or antibiotic, antifungal, antiparasitic, or antiviral treatment during the study period
  • Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period
  • Present use of probiotics/nutritional supplements. (Note: Use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet allowed)
  • Participation in a structured weight-loss program within the past 2 months
  • Change in body weight ≥5% within the past month
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  • Excess alcohol consumption; with an alcoholic drink defined as 12 fluid ounces of beer (5% alcohol), 5 fluid ounces of wine (12% alcohol) or 1.5 fluid ounces of 80 proof distilled spirits
  • Women: More than 2 alcoholic drinks/day or more than 7 drinks/week
  • Men: More than 3 alcoholic drinks/day or more than 10 drinks/week
  • Travel outside United States within 30 days of study entry
  • Planned travel outside United States during study period
  • Use of an experimental drug within 30 days prior to study entry
  • Known milk, peanut, tree nut, wheat, soy or shellfish allergy
  • Diagnosis of a sexually transmitted disease including, but not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and hepatitis C
  • Hospitalization during last 3 months (Same day surgery center procedures allowed)
  • Active GI disease
  • Gastrointestinal tract surgery (appendectomy and cholecystectomy allowed)
  • Cystic fibrosis
  • Any condition deemed by the investigator to disqualify subject

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Juno Research, LLC

    Houston, Texas, 77074

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Science 37

    Torrance, California, 90505

  • Orange County Research Center

    Tustin, California, 92780

  • Northside Medical Center

    Youngstown, Ohio, 44505

Other trials in United States

About this study

Official title: An Placebo-Controlled Clinical Nutrition Study to Evaluate the Metabolic Effects of Two Medical Food Products in Subjects With Type 2 Diabetes Treated With Diet and Exercise Alone or in Combination With Metformin ± Sulfonylurea

This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were safety, glucose AUC during meal tolerance test and C reactive protein (CRP)..

Read the detailed description

Targeting the microbiome for treating metabolic syndrome has been gaining traction with multiple population studies demonstrating a difference between healthy individuals and patients with metabolic syndrome. Whole Biome has identified and created two medical food formulations (MFFs) aimed at improving metabolic syndrome via two mechanisms of action targeting the microbiome: (1) increasing butyrate production and (2) increasing mucin regulation.

This randomized, parallel-group, placebo-controlled, double-blinded study assesses the safety and metabolic effects of 2 MFFs on glucose control and the generalized inflammatory state associated with Type 2 Diabetes. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards. The target population was patients with Type 2 Diabetes who either had not been treated with antidiabetic agents or treated with metformin +/- a sulfonylurea. Subjects were randomized in a balanced manner to receive capsules containing placebo, WBF10 or WBF11.

Being tested
WB-010, WB-011, Placebo
Keywords
glucose control, inflammation, safety, microbiome
Medical subject headings
Diabetes Mellitus, Type 2, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WB-010Other

    Medical food formulation

  • WB-011Other

    WB-011 medical food product

  • PlaceboOther

    Placebo Capsules identical to those containing WB-010 and WB-011.

Study groups in NCT03893422
Study groupRoleWhat they receive
WB-010Experimental3 capsules administered twice daily with morning and evening meal for 12 weeks
Receives: Other: WB-010
WB-011Experimental3 capsules administered twice daily with morning and evening meal for 12 weeks
Receives: Other: WB-011
PlaceboPlacebo comparator3 capsules administered twice daily with morning and evening meal for 12 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-hour plasma glucose AUC

    Change in area under plasma glucose concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test

    Measured: From Baseline to Week 12

  2. CRP

    Change in c-reactive protein concentration

    Measured: From Baseline to Week 12

Secondary outcomes (16)

  1. Incremental glucose AUC

    Change in area under plasma glucose concentration versus time curve (AUC) above the fasting plasma glucose level during standardized 3-hour Meal Tolerance Test

    Measured: From Baseline to Week 12

  2. Hemoglobin A1c

    Change in A1c

    Measured: From Baseline to Week 4 and Week 12

  3. Fasting plasma glucose concentration

    Change in fasting plasma glucose concentration

    Measured: From Baseline to Weeks 4, 8 and 12

  4. Fasting plasma insulin concentration

    Change in fasting plasma insulin concentration

    Measured: Baseline to Weeks 4, 8 and 12

  5. Plasma insulin AUC

    Change in area under plasma insulin concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test

    Measured: From Baseline to Week 12

  6. Homeostatic Model Assessment (HOMA) of Insulin Resistance (IR)

    Change in HOMA-IR

    Measured: From Baseline to Week 12

  7. Matsuda index

    Change in Matsuda index

    Measured: From Baseline to Week 12

  8. Fasting Lipid Panel

    Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides

    Measured: From Baseline to Week 12

  9. Inflammatory markers

    Change in concentrations of interleukin-6, interleukin-10, tumor growth factor-α and T-cell growth factor-beta

    Measured: From Baseline to Week 12

  10. Body weight in kilograms

    Change in body weight in kilograms

    Measured: From Baseline to Weeks 2, 4, 8 and 12

  11. Body Mass Index (BMI)

    BMI = weight in kg/m2

    Measured: At Baseline

  12. Waist Circumference

    Change in Waist Circumference

    Measured: From Baseline to Weeks 2, 4, 8 and 12

  13. Fecal Microbiome Profile

    Change in Fecal Microbiome Profile assessed by DNA sequencing

    Measured: From Baseline to Week 12

  14. Adverse Events

    Number of participants with adverse events related to therapy

    Measured: From Baseline to Week 12

  15. Laboratory (Chemistry panel + CBC) Values

    Number of Participants With Abnormal Laboratory Values Related to Therapy

    Measured: From Baseline to Week 12

  16. Hospital Anxiety and Depression Scale

    Subjects respond to 14 questions; 7 anxiety focused and 7 depression focused. Responses of "not at all", "not much", "sometimes" and "definitely" are translated to a numerical score of 0 to 4 respectively. For 2 of the depression related questions, the scoring scale is reversed. The individual numerical scores are added to provide an overall score which is interpreted as follows: 0 to 7 graded a non-case, 8 to 10 graded a borderline case and 11+ graded a case. An increase in the overall numerical score from baseline to Week 12 represents worsening and a decrease in the numerical score from baseline to Week 12 represents improvement.

    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.

  1. First posted28 Mar 2019
  2. Study start22 Oct 2017
  3. Primary completion16 Aug 2018
  4. Study completion14 Sep 2018

Resources

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
Model description
Balanced randomization across 3 arms: formulation WB-010, formulation WB-011 and placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893422
Sponsor's protocol ID
WB201-202
Status last verified
Feb 2020
First submitted
13 Mar 2019
Last updated
27 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.

    PubMed 32675291

Questions about this trial

What is this clinical trial studying?

A study testing WB-010 and WB-011 in people with Type 2 Diabetes Mellitus, run by Pendulum Therapeutics at 5 sites 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 13 inclusion and 19 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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.

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?

3-hour plasma glucose AUC (time frame: From Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03893422, which also lists 1 linked publication.

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 27 Feb 2020.

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