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SimpliciT1: Evaluation of TTP399 in Patients With Type 1 Diabetes

Sponsor
vTv Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03335371
Collaborator
Juvenile Diabetes Research Foundation (Other)
115
Enrollment
15
Locations
2
Arms
26.4
Actual Duration (Months)
7.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
115 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 :
Oct 25, 2017
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Jan 6, 2020

Arms and Interventions

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 800 mg taken once daily for 12 weeks
Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c from baseline at 12 weeks [Day 1 to Week 12]

Secondary Outcome Measures

  1. Adverse Events [Week -2 to Week 13]

  2. Time in target glycemic range (70-180 mg/dL) [Week -2 to Week 12]

  3. Time in hyperglycemic range (Level 1 > 180 mg/dL, Level 2 (>250 mg/dL) [Week -2 to Week 12]

  4. Time in hypoglycemic range (Level 1 < 70 mg/dL, Level 2 < 54 mg/dL) [Week -2 to Week 12]

  5. Change from baseline in total daily insulin dose [Week -2 to Week 12]

  6. Change from baseline of meal time bolus insulin [Week -2 to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USC Westside Center for Diabetes Beverly Hills California United States 90211
2 AMCR Institute Escondido California United States 92025
3 University of Colorado Barbara Davis Center Aurora Colorado United States 80045
4 Atlanta Diabetes Associate Atlanta Georgia United States 30318
5 Rocky Mountain Diabetes Center Idaho Falls Idaho United States 83404
6 Iowa Diabetes Research West Des Moines Iowa United States 50265
7 Mountain Diabetes and Endocrine Center Asheville North Carolina United States 28803
8 UNC Diabetes Care Center Chapel Hill North Carolina United States 27517
9 Duke University Diabetes Research Clinic Durham North Carolina United States 27710
10 Diabetes & Endocrinology Consultants Morehead City North Carolina United States 28557
11 PMG Research of Wilmington Wilmington North Carolina United States 28401
12 Wake Forest Winston-Salem North Carolina United States 27104
13 Intend Research Norman Oklahoma United States 73069
14 Dallas Diabetes Research Center Dallas Texas United States 75230
15 University of Washington Medicine Diabetes Institute Seattle Washington United States 98109

Sponsors and Collaborators

  • vTv Therapeutics
  • Juvenile Diabetes Research Foundation

Investigators

  • Study Director: Carmen Valcarce, Ph.D., vTv Therapeutics, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
vTv Therapeutics
ClinicalTrials.gov Identifier:
NCT03335371
Other Study ID Numbers:
  • TTP399-203
  • JDRF#2-IND-2018-500
First Posted:
Nov 7, 2017
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 27, 2020