Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

NCT04228003 | Withdrawn

• 1 other identifier: Pendulum D2D
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes; Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

• Decreased Gastrointestinal Symptoms

  Mean change from baseline in overall Gastrointestinal Symptom Rating Scale (GSRS) scores. The GSRS is a 15-item self-administered questionnaire related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort).

  6 weeks

Secondary Outcomes (7)

• Increased time in glucose range

  6 weeks

• Decreased time in hyperglycemic range

  6 weeks

• Decreased time in hypoglycemic range

  6 weeks

• Improvement in A1C

  6 weeks

• Improvement in fructosamine level

  6 weeks

Study Arms (1)

Pendulum

EXPERIMENTAL

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.

Dietary Supplement: Pendulum Glucose Control formulation for T2D

Interventions

Pendulum Glucose Control formulation for T2D 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℃.

Pendulum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Pendulum Therapeutics: collaborator

Study Sites (1)

USC Westside Center for Diabetes

Los Angeles, California, 90211, United States

Location

Study Officials

• Anne L Peters, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Clinical Scholar

Model Details: The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with gastrointestinal complaints.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: January 15, 2021
• Primary Completion: February 14, 2022
• Study Completion: June 14, 2022
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)