Clinical trial NCT06334133: Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Official title: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in incidence of Level 2 or Level 3 hypoglycemia
timeFrame: 26 weeks
Secondary outcomes:
measure: To assess the change in HbA1c
timeFrame: 26 weeks
measure: To assess the effects of treatment on CGM-based metrics for glycemic control
timeFrame: 26 weeks
measure: To assess the effects of treatment on the incidence of diabetic ketoacidosis
timeFrame: 26 weeks
measure: To assess the effects of treatment on insulin dosing
timeFrame: 18 weeks
measure: To assess the effects of treatment on body weight
timeFrame: 26 weeks
measure: To assess the incidence of treatment emergent adverse events
timeFrame: 26 weeks
measure: To assess the incidence of treatment emergent adverse events leading to discontinuation
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Advanced Metabolic Care & Research Institute, Inc. (AMCR)
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Englewood
country: United States
facility: Denver Endocrinology Diabetes and Thyroid Center
state: Colorado
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Columbus
country: United States
facility: Centricity Research - Columbus
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Sparks
country: United States
facility: Vector Clinical Trials
state: Nevada
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman Center for Advanced Medicine
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology, P.A
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research - Dallas
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates PA
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute - Ogden
state: Utah
Study officials:
affiliation: vTv Therapeutics
name: Thomas Strack, MD
role: STUDY_DIRECTOR
References: