Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Phase 3 – large-scale trial before approval
Conditions:
Diabetes Mellitus, Type 1
Sponsor: vTv Therapeutics
trial.available_in:
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Overview
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
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.
Who can participate
Inclusion Criteria:
* Individuals ≥18 years
* Diagnosed T1DM with a minimum of 3 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 been on a CGM device for at least 3 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
Interventions
Cadisegliatin 800 mg QD
DRUG
Cadisegliatin 800 mg BID
DRUG
Placebo
DRUG
Locations
58
United States (58)
AMC Community Endocrinology
Albany , New York
Accellacare - McFarland
Ames , Iowa
NOT_YET_RECRUITING
Atlanta Diabetes Associates
Atlanta , Georgia
Texas Diabetes and Endocrinology, P.A
Austin , Texas
MedStar Good Samaritan Hospital
Baltimore , Maryland
Paradigm Clinical Research
Boise , Idaho
Diabetes & Endocrinology Associates of Stark County, Inc
Canton , Ohio
East Coast Institute for Research, LLC
Canton , Georgia
University of North Carolina at Chapel Hill
Chapel Hill , North Carolina
Javarra Inc.
Charlotte , North Carolina
BayCare Health Systems
Clearwater , Florida
Centricity Research - Columbus
Columbus , Georgia
John Muir Physician Network Clinical Research Center
Concord , Ohio
ALL Medical Research, LLC
Cooper City , Florida
WITHDRAWN
Velocity Clinical Research - Dallas
Dallas , Texas
Denver Endocrinology Diabetes and Thyroid Center
Englewood , Colorado
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido , California
Profound Research LLC
Farmington Hills , Michigan
MD Studies, Inc
Fountain Valley , California
Physician's East PA
Greenville , North Carolina
AME Clinical Research
Huntington Beach , California
DM Clinical Research
Indianapolis , Indiana
310 Clinical Research
Inglewood , California
Scripps Whittier Diabetes Institute
La Jolla , California
Excel Clinical Research
Las Vegas , Nevada
Palm Research Center
Las Vegas , Nevada
Palm Research Center
Las Vegas , Nevada
Johnson County Clin-Trials, LLC
Lenexa , Kansas
Baptist Health Center for Clinical Research
Little Rock , Arkansas
The Jones Center Clinical Research, LLC
Macon , Georgia
Tekton Research, LLC
McKinney , Texas
Velocity Clinical Research - Medford
Medford , Oregon
Velocity Clinical Research
Medford , Oregon
SMS Clinical Research LLC
Mesquite , Texas
Southern Endocrinology Associates PA
Mesquite , Texas
Excellence Medical and Research
Miami Gardens , Florida
Paradigm Clinical Research - Modesto
Modesto , California
Lucas Research, Inc
Morehead City , North Carolina
Amicis Research Center
Northridge , California
Advanced Research Institute - Ogden
Ogden , Utah
WITHDRAWN
University of Pennsylvania Perelman Center for Advanced Medicine
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