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

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ClinicalTrials.gov Identifier: NCT03335371
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
vTv Therapeutics

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: TTP399 Drug: Placebo Oral Tablet Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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 dose TBD for 12 weeks

Placebo Comparator: Placebo Drug: Placebo Oral Tablet
Phase 2: Participants will receive Placebo oral tablets for 12 weeks




Primary Outcome Measures :
  1. Change in HbA1c from baseline at 12 weeks [ Time Frame: Day 1 to Week 12 ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Week -2 to Week 13 ]
  2. Time in target glycemic range (70-180 mg/dL) [ Time Frame: Week -2 to Week 12 ]
  3. Time in hyperglycemic range (Level 1 > 180 mg/dL, Level 2 (>250 mg/dL) [ Time Frame: Week -2 to Week 12 ]
  4. Time in hypoglycemic range (Level 1 < 70 mg/dL, Level 2 < 54 mg/dL) [ Time Frame: Week -2 to Week 12 ]
  5. Change from baseline in total daily insulin dose [ Time Frame: Week -2 to Week 12 ]
  6. Change from baseline of meal time bolus insulin [ Time Frame: Week -2 to Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (including previous treatment with TTP399) or any therapeutic protein or antibody within 90 days prior to Screening Visit.
  • Living in the same household or related to another participant in this study.
  • Hypoglycemia unawareness
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335371


Contacts
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Contact: Jennifer Freeman, Ph.D. (336) 841-0300 ext 120 clinicaltrials@vtvtherapeutics.com

Locations
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United States, California
Site 05 Recruiting
Escondido, California, United States, 92025
United States, North Carolina
Site 01 Recruiting
Chapel Hill, North Carolina, United States, 27517
Site 03 Recruiting
Durham, North Carolina, United States, 27710
Site 04 Recruiting
Morehead City, North Carolina, United States, 28557
Site 02 Recruiting
Winston-Salem, North Carolina, United States, 27104
Sponsors and Collaborators
vTv Therapeutics
Juvenile Diabetes Research Foundation
Investigators
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Study Director: Carmen Valcarce, Ph.D. vTv Therapeutics, LLC

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Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT03335371     History of Changes
Other Study ID Numbers: TTP399-203
JDRF#2-IND-2018-500 ( Other Identifier: JDRF International )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases