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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335371
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
vTv Therapeutics

Tracking Information
First Submitted Date  ICMJE October 31, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE October 25, 2017
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
Change in HbA1c from baseline at 12 weeks [ Time Frame: Day 1 to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • Adverse Events [ Time Frame: Week -2 to Week 13 ]
  • Time in target glycemic range (70-180 mg/dL) [ Time Frame: Week -2 to Week 12 ]
  • Time in hyperglycemic range (Level 1 > 180 mg/dL, Level 2 (>250 mg/dL) [ Time Frame: Week -2 to Week 12 ]
  • Time in hypoglycemic range (Level 1 < 70 mg/dL, Level 2 < 54 mg/dL) [ Time Frame: Week -2 to Week 12 ]
  • Change from baseline in total daily insulin dose [ Time Frame: Week -2 to Week 12 ]
  • Change from baseline of meal time bolus insulin [ Time Frame: Week -2 to Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Adverse Events [ Time Frame: Day 1 to Week 13 ]
  • Time in target glycemic range (70-180 mg/dL) [ Time Frame: Day 1 to Week 12 ]
  • Time in hyperglycemic range (Level 1 > 180 mg/dL, Level 2 (>250 mg/dL) [ Time Frame: Day 1 to Week 12 ]
  • Time in hypoglycemic range (Level 1 < 70 mg/dL, Level 2 < 54 mg/dL) [ Time Frame: Day 1 to Week 12 ]
  • Change from baseline in total daily insulin dose [ Time Frame: Day 1 to Week 12 ]
  • Change from baseline of meal time bolus insulin [ Time Frame: Day 1 to Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of TTP399 in Patients With Type 1 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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
  • Drug: Placebo Oral Tablet
    Phase 2: Participants will receive Placebo oral tablets for 12 weeks
Study Arms  ICMJE
  • Experimental: TTP399 400 mg
    Interventions:
    • Drug: TTP399
    • Drug: TTP399
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
115
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
126
Actual Study Completion Date  ICMJE January 6, 2020
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335371
Other Study ID Numbers  ICMJE TTP399-203
JDRF#2-IND-2018-500 ( Other Identifier: JDRF International )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party vTv Therapeutics
Study Sponsor  ICMJE vTv Therapeutics
Collaborators  ICMJE Juvenile Diabetes Research Foundation
Investigators  ICMJE
Study Director: Carmen Valcarce, Ph.D. vTv Therapeutics, LLC
PRS Account vTv Therapeutics
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP