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Completed

NCT Number: NCT03335371

Evaluation of TTP399 in Patients With Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

USC Westside Center for Diabetes, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTP399

Drug

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

Placebo oral tablet

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. Sentinel - Maximum Drug Concentration (Cmax)

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

  4. Sentinel - Time to Maximum Concentration (Tmax)

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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.

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

vTv Therapeutics

Industry

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Acronym: SimpliciT1

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 7, 2017
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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