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 the treatment of Type 1 Diabetes (T1D). It is currently in Phase 3 clinical development and has been granted Breakthrough Therapy designation by the FDA.
Cadisegliatin is a small molecule designed to work as an adjunctive therapy to insulin in Type 1 Diabetes. Its specific molecular target has not been disclosed, but it is being studied for its potential to improve glycemic control when added to insulin therapy.
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's safety and efficacy in patients with Type 1 Diabetes.
Cadisegliatin is currently in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA. The drug is investigational and has not yet been approved for commercial use.
Cadisegliatin is being studied in two clinical trials. The Phase 3 trial (NCT06334133) is active but not recruiting, with 150 participants in the United States and Puerto Rico. A Phase 2 trial (NCT07616206) is planned for patients using hybrid closed loop systems, with 40 participants in the United States.
Cadisegliatin 800 mg QD refers to the once-daily 800 mg dosing regimen of Cadisegliatin. It is the same drug, with the name indicating the specific dose and frequency being studied in clinical trials.