Evaluation of TTP399 in Patients With Type 1 Diabetes

NCT03335371 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TTP399-203JDRF#2-IND-2018-500
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (4)

• Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

  To evaluate the change in glycosylated hemoglobin (HbA1C) in Part 1 and Part 2 participants following multiple-day dosing (at 12 weeks) in subjects with T1MD. Sentinel participants were not evaluated for a change in HbA1C.

  Baseline (Day 1) to Week 13

• Sentinel - Area Under the Concentration Time Curve (AUC)

  AUC for Day 1 per dose level (400 mg, 800 mg, and 1200 mg) is AUC from 0 to 9 hours.

  Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.

• Sentinel - Maximum Drug Concentration (Cmax)

  Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.

• Sentinel - Time to Maximum Concentration (Tmax)

  Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.

Secondary Outcomes (8)

• Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL)

  Baseline (Day 1) to Week 12

• Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL)

  Baseline (Day 1) to Week 12

• Percent Change From Baseline Time in Hypoglycemia (< 70 mg/dL)

  Baseline (Day 1) to Week 12

• Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL)

  Baseline (Day 1) to Week 12

• Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL)

  Baseline (Day 1) to Week 12

Study Arms (2)

TTP399 400 mg

EXPERIMENTAL

Drug: TTP399

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

TTP399 DRUG

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

TTP399 400 mg

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• vTv Therapeutics: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (15)

USC Westside Center for Diabetes

Beverly Hills, California, 90211, United States

Location

AMCR Institute

Escondido, California, 92025, United States

Location

University of Colorado Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Atlanta Diabetes Associate

Atlanta, Georgia, 30318, United States

Location

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, 83404, United States

Location

Iowa Diabetes Research

West Des Moines, Iowa, 50265, United States

Location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

UNC Diabetes Care Center

Chapel Hill, North Carolina, 27517, United States

Location

Duke University Diabetes Research Clinic

Durham, North Carolina, 27710, United States

Location

Diabetes & Endocrinology Consultants

Morehead City, North Carolina, 28557, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27104, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

University of Washington Medicine Diabetes Institute

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 33622669 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

TTP399

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: vTv Therapeutics LLC

clinicaltrials@vtvtherapeutics.com

336-841-0300

Study Officials

• Carmen Valcarce, Ph.D.

  vTv Therapeutics, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 7, 2017
• Study Start: October 25, 2017
• Primary Completion: December 20, 2019
• Study Completion: January 6, 2020
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)