Evaluation of TTP399 in Patients With Type 1 Diabetes

NCT ID: NCT03335371

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-01-06

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1 diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TTP399 400 mg

Group Type: EXPERIMENTAL

TTP399

Intervention Type: DRUG

Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days

TTP399

Intervention Type: DRUG

Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Phase 2: Participants will receive Placebo oral tablets for 12 weeks

Interventions

TTP399

Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days

Intervention Type: DRUG

TTP399

Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks

Intervention Type: DRUG

Placebo Oral Tablet

Phase 2: Participants will receive Placebo oral tablets for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• People diagnosed with T1DM, confirmed diagnosis prior to 40 years of age and a diagnosed for minimum of 1 year.
• Type 1 diabetics using either continuous subcutaneous insulin infusion (with lispro or aspart) or multiple daily doses of insulin
• Willing to use adequate contraception
• No major surgeries or significant injuries within the past year and without an active infection.

Exclusion Criteria

• Diagnosis of T2DM, severely uncontrolled T1DM, maturity-onset diabetes of the young, insulin-requiring T2DM, other unusual or rare forms of diabetes mellitus, diabetes resulting from a secondary disease
• Receipt of an investigational product within 30 days of the Screening Visit or any therapeutic protein or antibody within 90 days prior to Screening Visit or any previous treatment with TTP399.
• Living in the same household or related to another participant in this study.
• Two severe episodes of hypoglycemia that required assistance by a third party within 3 months of Screening Visit
• Use of antidiabetic medications other than insulin 3 months prior to Screening Visit, systemic corticosteroids 1 month prior to Screening Visit, weight loss medication 2 weeks prior to Screening Visit, and antipsychotic medications 3 months prior to Screening Visit.
• Participation in any formal weight loss program or contemplating such therapy during the trial.
• Recent history of use of non-prescribed controlled substances or illicit drugs.
• Current alcoholism or a history of excessive alcohol consumption within 2 years prior to screening
• History or presence of symptomatic autonomic neuropathy or chronic gastrointestinal disease.
• Personal history of long QT syndrome.
• Blood donation of approximately 1 pint (500 mL) within 8 weeks before Screening Visit
• History of hemolytic anemia or chronic transfusion requirement.
• History of cancer, other than non-melanoma skin cancer or uterine cervical cancer that required therapy in the past 5 years.
• Breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

vTv Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Valcarce, Ph.D.

Role: STUDY_DIRECTOR

vTv Therapeutics, LLC

Locations

USC Westside Center for Diabetes

Beverly Hills, California, United States

AMCR Institute

Escondido, California, United States

University of Colorado Barbara Davis Center

Aurora, Colorado, United States

Atlanta Diabetes Associate

Atlanta, Georgia, United States

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, United States

Iowa Diabetes Research

West Des Moines, Iowa, United States

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, United States

UNC Diabetes Care Center

Chapel Hill, North Carolina, United States

Duke University Diabetes Research Clinic

Durham, North Carolina, United States

Diabetes & Endocrinology Consultants

Morehead City, North Carolina, United States

PMG Research of Wilmington

Wilmington, North Carolina, United States

Wake Forest

Winston-Salem, North Carolina, United States

Intend Research

Norman, Oklahoma, United States

Dallas Diabetes Research Center

Dallas, Texas, United States

University of Washington Medicine Diabetes Institute

Seattle, Washington, United States

Countries

United States

References

Klein KR, Freeman JLR, Dunn I, Dvergsten C, Kirkman MS, Buse JB, Valcarce C; SimpliciT1 research group. The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes. Diabetes Care. 2021 Apr;44(4):960-968. doi: 10.2337/dc20-2684. Epub 2021 Feb 23.

Reference Type: DERIVED

PMID: 33622669 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JDRF#2-IND-2018-500

Identifier Type: OTHER

Identifier Source: secondary_id

TTP399-203

Identifier Type: -

Identifier Source: org_study_id