Evaluation of TTP399 in Patients With Type 1 Diabetes (SimpliciT1)

June 12, 2023 updated by: vTv Therapeutics

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose, Adaptive Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of TTP399 in With Adult Patients Type 1 Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • USC Westside Center for Diabetes
      • Escondido, California, United States, 92025
        • AMCR Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Barbara Davis Center
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associate
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes Center
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes Research
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mountain Diabetes and Endocrine Center
      • Chapel Hill, North Carolina, United States, 27517
        • UNC Diabetes Care Center
      • Durham, North Carolina, United States, 27710
        • Duke University Diabetes Research Clinic
      • Morehead City, North Carolina, United States, 28557
        • Diabetes & Endocrinology Consultants
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington Medicine Diabetes Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo Oral Tablet
Phase 2: Participants will receive Placebo oral tablets for 12 weeks
Experimental: TTP399 400 mg
Drug: TTP399
Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days
Drug: TTP399
Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time Frame: Baseline (Day 1) to Week 13
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)
Time Frame: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
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)
Time Frame: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Sentinel - Time to Maximum Concentration (Tmax)
Time Frame: Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL)
Time Frame: Baseline (Day 1) to Week 12
To evaluate the change from baseline time in target range (24 hour)
Baseline (Day 1) to Week 12
Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL)
Time Frame: Baseline (Day 1) to Week 12
To evaluate the 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)
Time Frame: Baseline (Day 1) to Week 12
To evaluate the 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)
Time Frame: Baseline (Day 1) to Week 12
To evaluate the change from baseline time in hypoglycemia (>180 mg/dL)
Baseline (Day 1) to Week 12
Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL)
Time Frame: Baseline (Day 1) to Week 12
To evaluate the change from baseline time in hypoglycemia (>250 mg/dL)
Baseline (Day 1) to Week 12
Percent Change From Baseline in Total Daily Insulin Use
Time Frame: Baseline (Day 1) to Week 12
To evaluate the percent change from baseline in total daily insulin use at week 12.
Baseline (Day 1) to Week 12
Change From Baseline in Bolus Insulin Use
Time Frame: Baseline (Day 1) to Week 12
To evaluate the change from baseline in bolus insulin use
Baseline (Day 1) to Week 12
Change From Baseline in Basal Insulin Use
Time Frame: Baseline (Day 1) to Week 12
To evaluate the change from baseline in basal insulin use
Baseline (Day 1) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
vTv Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Juvenile Diabetes Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Carmen Valcarce, Ph.D., vTv Therapeutics, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTP399-203
  • JDRF#2-IND-2018-500 (Other Identifier: JDRF International)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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