Trials Today

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) 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

Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752 85260

Baptist Health Center for Clinical Research
Little Rock 4119403, Arkansas 4099753 72205

Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido 5346827, California 5332921 92025

MD Studies, Inc
Fountain Valley 5350207, California 5332921 92078

AME Clinical Research
Huntington Beach 5358705, California 5332921 92647

310 Clinical Research
Inglewood 5359488, California 5332921 90301

Scripps Whittier Diabetes Institute
La Jolla 5363943, California 5332921 92037

Paradigm Clinical Research - Modesto
Modesto 5373900, California 5332921 95355

Paradigm Clinical Research Centers LLC
San Diego 5391811, California 5332921 92108

Acclaim Clinical Research
San Diego 5391811, California 5332921 92120

Focus Clinical Research
West Hills 8030162, California 5332921 91307

Denver Endocrinology Diabetes and Thyroid Center
Englewood 5421250, Colorado 5417618 80113

BayCare Health Systems
Clearwater 4151316, Florida 4155751 33756

ALL Medical Research, LLC
Cooper City 4151824, Florida 4155751 33024

Excellence Medical and Research
Miami Gardens 4164167, Florida 4155751 33169

Metabolic Research Institute, Inc
West Palm Beach 4177887, Florida 4155751 33413

Atlanta Diabetes Associates
Atlanta 4180439, Georgia 4197000 30318

East Coast Institute for Research, LLC
Canton 4186213, Georgia 4197000 30114

Centricity Research - Columbus
Columbus 4188985, Georgia 4197000 31904

The Jones Center Clinical Research, LLC
Macon 4207400, Georgia 4197000 31210

Endocrine Research Solutions, Inc
Roswell 4219934, Georgia 4197000 30076

Iowa Diabetes and Endocrinology Research Center
West Des Moines 4881346, Iowa 4862182 50265

Johnson County Clin-Trials, LLC
Lenexa 4274356, Kansas 4273857 66219

Profound Research LLC
Farmington Hills 4992523, Michigan 5001836 48334

Excel Clinical Research
Las Vegas 5506956, Nevada 5509151 89109

Palm Research Center
Las Vegas 5506956, Nevada 5509151 89128

Vector Clinical Trials
Sparks 5512862, Nevada 5509151 89436

Jacobi Medical Center
The Bronx 5110266, New York 5128638 10461

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514

Physician's East PA
Greenville 4469160, North Carolina 4482348 27834

Lucas Research, Inc
Morehead City 4480153, North Carolina 4482348 28557

Diabetes & Endocrinology Associates of Stark County, Inc
Canton 5149222, Ohio 5165418 44718

John Muir Physician Network Clinical Research Center
Concord 4509252, Ohio 5165418 94520

Velocity Clinical Research - Medford
Medford 5740099, Oregon 5744337 97504

University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104

Texas Diabetes and Endocrinology, P.A
Austin 4671654, Texas 4736286 78731

Velocity Clinical Research - Dallas
Dallas 4684888, Texas 4736286 75230

Southern Endocrinology Associates PA
Mesquite 4710826, Texas 4736286 75149

Diabetes & Glandular Disease Clinic, P.A.
San Antonio 4726206, Texas 4736286 78229

Consano Clinical Research
Shavano Park 4728147, Texas 4736286 78231

University of Washington Diabetes Institute
Seattle 5809844, Washington 5815135 98109

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.