Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

NCT ID: NCT04228003

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-06-14

Brief Summary

The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agents to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes.

Detailed Description

A high prevalence of gastrointestinal (GI) symptoms exist in both type 1 and type 2 diabetes that affect the quality of life negatively and substantially, although the underlying pathophysiology and relationship with glycemic control remain unclear. The current study aims to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes mellitus who are already on a stable dose of metformin alone and/or alongside other oral or injectable anti-hyperglycemic agents (sulfonylurea agents, DPPIV inhibitor,Glucagon-like peptide (GLP)-1 agonist, sodium-glucose cotransporter (SGLT)-2 inhibitor and/or insulin) and with present GI symptoms. The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agent and an HbA1C between 6.5% and 9.5%. The study will be 8 weeks in duration (2 weeks baseline and 6 weeks product intervention), with an option to continue to 6 months for those willing to continue taking the dietary supplement. As the study is observational and the data are to be used to for the purpose of evaluating improvement in GI symptoms during the intervention with Pendulum T2D there is no specific method to determine sample size.

Conditions

Type2 Diabetes; Gastrointestinal Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pendulum

Pendulum Glucose Control formulation for T2D will be taken twice daily - 1 capsule with the morning meal and 1 capsule with the evening meal for 8 weeks with an option of continuing up to 6 months.

Group Type: EXPERIMENTAL

Pendulum Glucose Control formulation for T2D

Intervention Type: DIETARY_SUPPLEMENT

All bacteria contained in the study product formulation are commensal organisms that have been repeatedly documented to inhabit the human GI tract under normal circumstances. Pendulum's Glucose Control Formulation consists of five human commensal microbial strains including butyrate producing and mucin-degrading strains. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS).

The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4℃.

Interventions

Pendulum Glucose Control formulation for T2D

All bacteria contained in the study product formulation are commensal organisms that have been repeatedly documented to inhabit the human GI tract under normal circumstances. Pendulum's Glucose Control Formulation consists of five human commensal microbial strains including butyrate producing and mucin-degrading strains. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS).

The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4℃.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Body mass index ≤ 45 kg/m2.
• Subjects with type 2 diabetes that are on a stable dose of one or more injectable or oral antihyperglycemia agents for at least 8 weeks prior to screening.
• HbA1c ≥ 6.5 % and ≤ 9.5% obtained at the screening visit.
• Subjects with any gastrointestinal symptoms including but not limited to heartburn, indigestion, diarrhea, constipation.
• Must be willing and be able to give written informed consent.

Exclusion Criteria

• Type 1 diabetes
• Pregnant, nursing or planning pregnancy
• Planning elective surgery in the next 8 weeks
• Current or planned use of steroids, orally or injected
• Diagnosis of irritable bowel disease , diverticulitis, other significant GI illness
• Co-existing severe health condition, such as active cancer or unstable cardiovascular disease/congestive heart failure.
• Severe allergy to tape or any component of the CGM device

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pendulum Therapeutics

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Anne Peters

Professor of Medicine, Clinical Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne L Peters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC Westside Center for Diabetes

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pendulum D2D

Identifier Type: -

Identifier Source: org_study_id