Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04047537
• Other study ID #: AFCRO-104
• Status: Terminated
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2022
• Source: Pendulum Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: May 30, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

• If female, must meet all the following criteria:

1. Not pregnant or breastfeeding

2. 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

Exclusion Criteria:

• 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

• Excess alcohol consumption; with an alcoholic drink defined as 284 ml of beer, lager, stout , 100 ml of wine or 35.5 ml spirits

1. Women: More than 11 standard drinks/week

2. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Medical Food Formulation 1
WBF-0011
• Medical Food Formulation 2
WBF-0011 (0.2X concentration)
• Placebo
Placebo Capsules identical to those containing Formulation 1 and 2

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Pendulum Therapeutics

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels	From Baseline to Week 12
Secondary	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)	Baseline to Weeks 2, 6, 9 and 12
Secondary	3-hour plasma glucose AUC	as measured by laboratory plasma glucose measurements during standardized 3-hour Meal Tolerance Test (MTT)	Baseline to Weeks 2, 6, 9 and 12
Secondary	3-hour blood glucose AUC	as measured by the CGM device at home during standardized 3-hour Meal Tolerance Test (MTT)	Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11.
Secondary	24-hour CGM	Time in range (70 to 180 mg/dL)/24-hour period	From Baseline to Week 12
Secondary	Fasting Lipid Panel	Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides	From Baseline to Week 12
Secondary	Body weight	Change in body weight in kilograms	From Baseline to Week 12
Secondary	Adverse Events	Number of participants with adverse events related to therapy	From Baseline to Week 12
Secondary	Change from baseline in Laboratory Chemistry Values	Number of Participants With Abnormal Laboratory Values Related to Therapy	From Baseline to Week 12
Secondary	Change from baseline in Laboratory Complete Blood count Values	Number of Participants With Abnormal Laboratory Values Related to Therapy	From Baseline to Week 12