Evaluation of TTP399 in Patients With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335371
• Other study ID #: TTP399-203
• Secondary ID: JDRF#2-IND-2018-
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 25, 2017
• Est. completion date: January 6, 2020

Study information

• Verified date: June 2023
• Source: vTv Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: January 6, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• TTP399
Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days
• TTP399
Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks
• Placebo Oral Tablet
Phase 2: Participants will receive Placebo oral tablets for 12 weeks

Locations

Country	Name	City	State
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina
United States	Atlanta Diabetes Associate	Atlanta	Georgia
United States	University of Colorado Barbara Davis Center	Aurora	Colorado
United States	USC Westside Center for Diabetes	Beverly Hills	California
United States	UNC Diabetes Care Center	Chapel Hill	North Carolina
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Duke University Diabetes Research Clinic	Durham	North Carolina
United States	AMCR Institute	Escondido	California
United States	Rocky Mountain Diabetes Center	Idaho Falls	Idaho
United States	Diabetes & Endocrinology Consultants	Morehead City	North Carolina
United States	Intend Research	Norman	Oklahoma
United States	University of Washington Medicine Diabetes Institute	Seattle	Washington
United States	Iowa Diabetes Research	West Des Moines	Iowa
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
vTv Therapeutics	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 1) to Week 13
Primary	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.	Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Primary	Sentinel - Maximum Drug Concentration (Cmax)		Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Primary	Sentinel - Time to Maximum Concentration (Tmax)		Predose, 60, 90, 120, 150, 180, 240, 360 (6hr) and 540min (9hr) after dosing.
Secondary	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)	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline Time in Hypoglycemia (< 54 mg/dL)	To evaluate the change from baseline time in hypoglycemia (< 54 mg/dL)	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline Time in Hypoglycemia (< 70 mg/dL)	To evaluate the change from baseline time in hypoglycemia (< 70 mg/dL)	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline Time in Hyperglycemia (>180 mg/dL)	To evaluate the change from baseline time in hypoglycemia (>180 mg/dL)	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline Time in Hyperglycemia (>250 mg/dL)	To evaluate the change from baseline time in hypoglycemia (>250 mg/dL)	Baseline (Day 1) to Week 12
Secondary	Percent Change From Baseline in Total Daily Insulin Use	To evaluate the percent change from baseline in total daily insulin use at week 12.	Baseline (Day 1) to Week 12
Secondary	Change From Baseline in Bolus Insulin Use	To evaluate the change from baseline in bolus insulin use	Baseline (Day 1) to Week 12
Secondary	Change From Baseline in Basal Insulin Use	To evaluate the change from baseline in basal insulin use	Baseline (Day 1) to Week 12

External Links

•   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