Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes (CATT1)

Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Cadisegliatin 800 mg QD; Drug: Cadisegliatin 800 mg BID; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00907
    • Solace Clinical Research
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Granada Hills, California, United States, 91344
      • Amicis Research Center
    • Huntington Beach, California, United States, 92647
      • AME Clinical Research
    • Inglewood, California, United States, 90301
      • 310 Clinical Research
    • La Jolla, California, United States, 92037
      • Scripps Whittier Diabetes Institute
    • La Palma, California, United States, 90623
      • IMAX Clinical Trials
    • Modesto, California, United States, 95355
      • Paradigm Clinical Research - Modesto
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • San Diego, California, United States, 92108
      • Paradigm Clinical Research Centers LLC
    • Torrance, California, United States, 90502
      • The Lundquist Institute
    • West Hills, California, United States, 91307
      • Focus Clinical Research
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Denver Endocrinology Diabetes and Thyroid Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • BayCare Health Systems
    • West Palm Beach, Florida, United States, 33413
      • Metabolic Research Institute, Inc
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Columbus, Georgia, United States, 31904
      • Centricity Research - Columbus
    • Macon, Georgia, United States, 31210
      • The Jones Center Clinical Research, LLC
  • Idaho
    • Boise, Idaho, United States, 83709
      • Paradigm Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • DM Clinical Research
  • Iowa
    • Ames, Iowa, United States, 50010
      • Accellacare - McFarland
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • MedStar Good Samaritan Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Diabetes Research Center
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Profound Research LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
    • Reno, Nevada, United States, 89511
      • Vector Clinical Trials
  • New York
    • Albany, New York, United States, 12203
      • AMC Community Endocrinology
    • The Bronx, New York, United States, 10461
      • Jacobi Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28210
      • Javarra Inc.
    • Greenville, North Carolina, United States, 27834
      • Physician's East PA
    • Morehead City, North Carolina, United States, 28557
      • Centricity Research Morehead City Multispecialty
  • Ohio
    • Canton, Ohio, United States, 44718
      • Diabetes & Endocrinology Associates of Stark County, Inc
    • Concord, Ohio, United States, 94520
      • John Muir Physician Network Clinical Research Center
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Perelman Center for Advanced Medicine
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Circle Clinical Research
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology, P.A
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research - Dallas
    • McKinney, Texas, United States, 75069
      • Tekton Research, LLC
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates PA
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research LLC
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease Clinic, P.A.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington Diabetes Institute
    • Spokane, Washington, United States, 99202
      • Citta Clinical Research, LLC
    • Spokane, Washington, United States, 99218
      • Velocity Clinical Research - Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in incidence of Level 2 or Level 3 hypoglycemia	Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the change in HbA1c	Change from baseline in HbA1c in participants on cadisegliatin vs placebo.	26 weeks
To assess the effects of treatment on the incidence of diabetic ketoacidosis	Number of events of diabetic ketoacidosis participants on cadisegliatin vs placebo	26 weeks
To assess the effects of treatment on body weight	Change from baseline in mean body weight	26 weeks
To assess the effects of treatment on CGM-based metrics for glycemic control	Change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo	26 weeks
To assess the effects of treatment on insulin dosing	Change from baseline in average daily total insulin on cadisegliatin vs placebo	18 weeks
To assess the incidence of treatment emergent adverse events	Number of treatment emergent adverse events with cadisegliatin vs placebo	26 weeks
To assess the incidence of treatment emergent adverse events leading to discontinuation	Number of treatment emergent adverse events leading to discontinuation with cadisegliatin vs placebo	26 weeks
To assess the incidence of adverse events of special interest	Number of adverse events of special interests with cadisegliatin vs placebo	26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in incidence of Level 2 or Level 3 hypoglycemia	Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.	52 weeks
To assess the change in HbA1c	Change from baseline in HbA1c in participants on cadisegliatin vs placebo	52 weeks
To assess the effects of treatment on CGM-based metrics for glycemic control	To evaluate the change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo	52 weeks
To assess the incidence of adverse events	Evaluation and comparison of the number of adverse events with cadisegliatin vs placebo during the study	52 weeks
To assess the effects of treatment on the incidence of diabetic ketoacidosis	Percentage of participants with incidence of diabetic ketoacidosis on cadisegliatin vs placebo	52 weeks
To assess the effects of treatment on insulin dosing	Change from baseline in basal, bolus and total insulin dosing	52 weeks
To assess the effects of treatment on body weight	Change from baseline in mean body weight	52 weeks
High sensitivity C-reactive protein	Change from baseline of biomarkers	26 and 52 weeks
N-terminal pro brain [or B-type] natriuretic peptide	Change from baseline of biomarkers	26 and 52 weeks
Urinary albumin excretion ratio	Change from baseline of biomarkers	26 and 52 weeks
Estimated glomerular filtration rate	Change from baseline of biomarkers	26 and 52 weeks
8-item Diabetes Distress Scale (participant and partner or family member)	Change from baseline in PRO scores to assess the burden of hypoglycemia	26 and 52 weeks
Hypoglycemia Confidence Scale for participant and partner or family member	Change from baseline in PRO scores to assess the burden of hypoglycemia	26 and 52 weeks
11-item/Short Form Hypoglycemia Fear Scale	Change from baseline in PRO scores to assess the burden of hypoglycemia	26 and 52 weeks
Gold hypoglycemia awareness score	Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from 1 (always aware) to 7 (never aware).	26 and 52 weeks
Item 7 of Clarke hypoglycemia awareness scale	Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from less than 40 mg/dL to 79mg/dL.	26 and 52 weeks
Snyder's 1-item quality of sleep questionnaire	Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from 0 (terrible) to 10 (excellent).	26 and 52 weeks
World Health Organization-5 Well-Being Index	Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Ranges from not confident to very confident.	26 and 52 weeks

Collaborators and Investigators

• Sponsor: vTv Therapeutics
• Investigators: Study Director: Thomas Strack, MD, vTv Therapeutics

Publications and helpful links

Helpful Links

• T1D Exchange prescreening website

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; BID protein, human; TTP399
• Other Study ID Numbers: TTP399-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No