Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes (CATT1)

vTv Therapeutics

Status and phase: Suspended; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Placebo; Drug: Cadisegliatin 800 mg BID; Drug: Cadisegliatin 800 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06334133

TTP399-302

Details and patient eligibility

About

This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus.

Full description

Study TTP399-302 is a 52-week, Phase 3 trial designed to measure the relative efficacy of treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo over 26 weeks of continuous therapy.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 1 month 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 persistent, uncontrolled hypertension prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Cadisegliatin: 52 Week Double Blind Treatment Period - 800 mg QD

Experimental group

Description:

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 52-week treatment period.

Treatment:

Drug: Cadisegliatin 800 mg QD

Cadisegliatin: 52 Week Double Blind Treatment Period - 800 mg BID

Experimental group

Description:

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 52-week treatment period.

Treatment:

Drug: Cadisegliatin 800 mg BID

Placebo: 52 Week Double Blind Treatment Period

Placebo Comparator group

Description:

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 52-week treatment period.

Treatment:

Drug: Placebo