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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TTP399
TTP399
Placebo Oral Tablet
Sponsored by
vTv Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Westside Center for Diabetes
  • AMCR Institute
  • University of Colorado Barbara Davis Center
  • Atlanta Diabetes Associate
  • Rocky Mountain Diabetes Center
  • Iowa Diabetes Research
  • Mountain Diabetes and Endocrine Center
  • UNC Diabetes Care Center
  • Duke University Diabetes Research Clinic
  • Diabetes & Endocrinology Consultants
  • PMG Research of Wilmington
  • Wake Forest
  • Intend Research
  • Dallas Diabetes Research Center
  • University of Washington Medicine Diabetes Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TTP399 400 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
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.
Sentinel - Area Under the Concentration Time Curve (AUC)
AUC for Day 1 per dose level (400 mg, 800 mg, and 1200 mg) is AUC from 0 to 9 hours.
Sentinel - Maximum Drug Concentration (Cmax)
Sentinel - Time to Maximum Concentration (Tmax)

Secondary Outcome Measures

Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL)
To evaluate the change from baseline time in target range (24 hour)
Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL)
To evaluate the change from baseline time in hypoglycemia (< 54 mg/dL)
Percent Change From Baseline Time in Hypoglycemia (< 70 mg/dL)
To evaluate the change from baseline time in hypoglycemia (< 70 mg/dL)
Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL)
To evaluate the change from baseline time in hypoglycemia (>180 mg/dL)
Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL)
To evaluate the change from baseline time in hypoglycemia (>250 mg/dL)
Percent Change From Baseline in Total Daily Insulin Use
To evaluate the percent change from baseline in total daily insulin use at week 12.
Change From Baseline in Bolus Insulin Use
To evaluate the change from baseline in bolus insulin use
Change From Baseline in Basal Insulin Use
To evaluate the change from baseline in basal insulin use

Full Information

First Posted
October 31, 2017
Last Updated
June 12, 2023
Sponsor
vTv Therapeutics
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03335371
Brief Title
Evaluation of TTP399 in Patients With Type 1 Diabetes
Acronym
SimpliciT1
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
vTv Therapeutics
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TTP399 400 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TTP399
Intervention Description
Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
TTP399
Intervention Description
Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Phase 2: Participants will receive Placebo oral tablets for 12 weeks
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Description
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.
Time Frame
Baseline (Day 1) to Week 13
Title
Sentinel - Area Under the Concentration Time Curve (AUC)
Description
AUC for Day 1 per dose level (400 mg, 800 mg, and 1200 mg) is AUC from 0 to 9 hours.
Time Frame
Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Title
Sentinel - Maximum Drug Concentration (Cmax)
Time Frame
Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Title
Sentinel - Time to Maximum Concentration (Tmax)
Time Frame
Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Secondary Outcome Measure Information:
Title
Percent Change From Baseline Time in Target Glycemic Range (70-180 mg/dL)
Description
To evaluate the change from baseline time in target range (24 hour)
Time Frame
Baseline (Day 1) to Week 12
Title
Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL)
Description
To evaluate the change from baseline time in hypoglycemia (< 54 mg/dL)
Time Frame
Baseline (Day 1) to Week 12
Title
Percent Change From Baseline Time in Hypoglycemia (< 70 mg/dL)
Description
To evaluate the change from baseline time in hypoglycemia (< 70 mg/dL)
Time Frame
Baseline (Day 1) to Week 12
Title
Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL)
Description
To evaluate the change from baseline time in hypoglycemia (>180 mg/dL)
Time Frame
Baseline (Day 1) to Week 12
Title
Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL)
Description
To evaluate the change from baseline time in hypoglycemia (>250 mg/dL)
Time Frame
Baseline (Day 1) to Week 12
Title
Percent Change From Baseline in Total Daily Insulin Use
Description
To evaluate the percent change from baseline in total daily insulin use at week 12.
Time Frame
Baseline (Day 1) to Week 12
Title
Change From Baseline in Bolus Insulin Use
Description
To evaluate the change from baseline in bolus insulin use
Time Frame
Baseline (Day 1) to Week 12
Title
Change From Baseline in Basal Insulin Use
Description
To evaluate the change from baseline in basal insulin use
Time Frame
Baseline (Day 1) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Valcarce, Ph.D.
Organizational Affiliation
vTv Therapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
USC Westside Center for Diabetes
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
AMCR Institute
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
University of Colorado Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Atlanta Diabetes Associate
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Rocky Mountain Diabetes Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Iowa Diabetes Research
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Mountain Diabetes and Endocrine Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
UNC Diabetes Care Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Duke University Diabetes Research Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Diabetes & Endocrinology Consultants
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Intend Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Washington Medicine Diabetes Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33622669
Citation
Klein KR, Freeman JLR, Dunn I, Dvergsten C, Kirkman MS, Buse JB, Valcarce C; SimpliciT1 research group. The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes. Diabetes Care. 2021 Apr;44(4):960-968. doi: 10.2337/dc20-2684. Epub 2021 Feb 23.
Results Reference
derived
Links:
URL
https://doi.org/10.2337/dc20-2684
Description
The SimpliciT1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Adaptive Study of TTP399, a Hepatoselective Glucokinase Activator, for Adjunctive Treatment of Type 1 Diabetes

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Evaluation of TTP399 in Patients With Type 1 Diabetes

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