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...