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Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

Purpose

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

Condition

Diabetes Mellitus, Type 1

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Individuals ≥18 years - Diagnosed T1DM with a minimum of 5 years since diagnosis - Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3 mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening - HbA1c value of <9.5% at Screening - Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study - Must have used a CGM device for at least 3 consecutive months prior to Screening

Exclusion Criteria

Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease - Has been hospitalized for DKA within 3 months prior to Screening - Has uncontrolled hypothyroidism or hyperthyroidism - History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight - Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ - Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) within 90 days prior to the Screening or weight loss medications within 30 days prior to the Screening - Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study. - Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening - Has uncontrolled hypertension prior to Screening

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD	The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.	Drug: Cadisegliatin 800 mg QD Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. Other names: TTP399
Experimental Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID	The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.	Drug: Cadisegliatin 800 mg BID Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. Other names: TTP399
Placebo Comparator Placebo: 26 Week Double Blind Treatment Period	The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.	Drug: Placebo Placebo (insulin alone)

Recruiting Locations

Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido, California 92025

Scripps Whittier Diabetes Institute
La Jolla, California 92037

Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado 80113

ALL Medical Research, LLC
Cooper City, Florida 33024

Metabolic Research Institute, Inc
West Palm Beach, Florida 33413

Atlanta Diabetes Associates
Atlanta, Georgia 30318

Centricity Research - Columbus
Columbus, Georgia 31904

The Jones Center Clinical Research, LLC
Macon, Georgia 31210

Endocrine Research Solutions, Inc
Roswell, Georgia 30076

Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50265

Vector Clinical Trials
Sparks, Nevada 89436

Jacobi Medical Center
Bronx, New York 10461

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514

Lucas Research, Inc
Morehead City, North Carolina 28557

Velocity Clinical Research - Medford
Medford, Oregon 97504

University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104

Texas Diabetes and Endocrinology, P.A
Austin, Texas 78731

Velocity Clinical Research - Dallas
Dallas, Texas 75230

Southern Endocrinology Associates PA
Mesquite, Texas 75149

Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas 78229

Consano Clinical Research
Shavano Park, Texas 78231

More Details

NCT ID: NCT06334133
Status: Recruiting
Sponsor: vTv Therapeutics

Study Contact

Jennifer Freeman, Ph.D.
(336) 888-0435
clinicaltrials@vtvtherapeutics.com

Detailed Description

Study TTP399-302 is a 26-week, Phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo (insulin alone) over 26 weeks of continuous therapy.