Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cadisegliatin · 2 trials · 2 indications
Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.
Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
| Arm | Type | Description |
|---|---|---|
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD | EXPERIMENTAL | 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 | EXPERIMENTAL | 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_COMPARATOR | 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 800 mg QD: Double Blind, Randomized Crossover Trial Design | EXPERIMENTAL | If a patient is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the placebo QD along with their insulin treatment arm |
| Placebo: Double Blind, Randomized Crossover Trial Design | PLACEBO_COMPARATOR | If a patient is randomized to receive placebo QD along with their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment arm |
| Name | Type | Description |
|---|---|---|
| Cadisegliatin 800 mg QD | DRUG | Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. |
| Cadisegliatin 800 mg BID | DRUG | Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. |
| Placebo | DRUG | Placebo (insulin alone) |
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...
Cadisegliatin is an investigational small molecule being developed as an adjunctive therapy to insulin for people with Type 1 Diabetes (T1D). It is intended for adult patients who are using hybrid closed loop (HCL) systems or other insulin regimens. The drug is currently in clinical development and has not been approved by the FDA.
Cadisegliatin targets glucokinase, an enzyme that plays a role in glucose metabolism. By acting on glucokinase, the drug is designed to complement insulin therapy in managing blood sugar levels in Type 1 Diabetes. It is a small molecule therapy being investigated for its potential to improve glycemic control.
Cadisegliatin is being developed by vTv Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VTVT. The company is conducting clinical trials to evaluate the drug as an adjunctive treatment to insulin in patients with Type 1 Diabetes.
Cadisegliatin is in Phase 3 clinical development for Type 1 Diabetes. It has received Breakthrough Therapy designation from the FDA, which is intended to expedite the development and review of drugs that show promise for serious conditions. The drug is investigational and not yet approved.
Cadisegliatin is being studied in two clinical trials. NCT06334133 is a Phase 3, randomized, double-blind, placebo-controlled trial enrolling 150 adults with Type 1 Diabetes in the United States and Puerto Rico. NCT07616206 is a Phase 2 trial enrolling 40 adults using hybrid closed loop systems in the United States.
Cadisegliatin 800 mg QD refers to the specific dose and regimen of Cadisegliatin being studied, which is 800 milligrams taken once daily. This is the same drug, with the name indicating the dosage form used in clinical trials. The active ingredient is Cadisegliatin.