Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: Cadisegliatin 800 mg QDDrug: Cadisegliatin 800 mg BIDDrug: Placebo
- Registration Number
- NCT06334133
- Lead Sponsor
- vTv Therapeutics
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD Cadisegliatin 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. Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID Cadisegliatin 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. Placebo: 26 Week Double Blind Treatment Period Placebo 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.
- Primary Outcome Measures
Name Time Method Change in incidence of Level 2 or Level 3 hypoglycemia 26 weeks Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.
- Secondary Outcome Measures
Name Time Method To assess the effects of treatment on insulin dosing 18 weeks Change from baseline in average daily total insulin on cadisegliatin vs placebo
To assess the incidence of treatment emergent adverse events leading to discontinuation 26 weeks Number of treatment emergent adverse events leading to discontinuation with cadisegliatin vs placebo
To assess the incidence of treatment emergent adverse events 26 weeks Number of treatment emergent adverse events with cadisegliatin vs placebo
To assess the change in HbA1c 26 weeks Change from baseline in HbA1c in participants on cadisegliatin vs placebo.
To assess the effects of treatment on CGM-based metrics for glycemic control 26 weeks Change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo
To assess the effects of treatment on the incidence of diabetic ketoacidosis 26 weeks Number of events of diabetic ketoacidosis participants on cadisegliatin vs placebo
To assess the effects of treatment on body weight 26 weeks Change from baseline in mean body weight
Trial Locations
- Locations (20)
Scripps Whittier Diabetes Institute
🇺🇸La Jolla, California, United States
Vector Clinical Trials
🇺🇸Sparks, Nevada, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Southern Endocrinology Associates PA
🇺🇸Mesquite, Texas, United States
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
🇺🇸Escondido, California, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Endocrine Research Solutions, Inc
🇺🇸Roswell, Georgia, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
Velocity Clinical Research - Dallas
🇺🇸Dallas, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
Denver Endocrinology Diabetes and Thyroid Center
🇺🇸Englewood, Colorado, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
Advanced Research Institute - Ogden
🇺🇸Ogden, Utah, United States
Metabolic Research Institute, Inc
🇺🇸West Palm Beach, Florida, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Centricity Research - Columbus
🇺🇸Columbus, Georgia, United States
Asheville Clinical Research
🇺🇸Asheville, North Carolina, United States
Texas Diabetes and Endocrinology, P.A
🇺🇸Austin, Texas, United States
Velocity Clinical Research - Medford
🇺🇸Medford, Oregon, United States