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ISIS 113715 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | Sulfonylurea + 100 mg/week ISIS 113715 or placebo |
| B | PLACEBO_COMPARATOR | Sulfonylurea + 200 mg/week ISIS 113715 or placebo |
| Name | Type | Description |
|---|---|---|
| ISIS 113715 | DRUG | doses of 100 and 200 mg per week |
Inclusion Criteria: * Type 2 diabetes mellitus of less than or equal to eight years in duration, diagnosed according to American Diabetes Association criteria * Fasting serum glucose from 150 to 270 mg/dL at screening visit * HbA1c from 7.5 to 11.0 at screening * Being treated with at least 10 mg/d...
ISIS 113715 is an investigational drug developed for the treatment of Type 2 Diabetes Mellitus. It was studied in patients with Type 2 Diabetes Mellitus, including those not previously treated and those already receiving sulfonylurea therapy. It is not an approved medicine and remains in clinical development.
ISIS 113715 targets PTP-1B, also known as protein tyrosine phosphatase 1B, a protein target involved in metabolic regulation. By acting on PTP-1B, the drug was designed to address the metabolic pathway relevant to Type 2 Diabetes Mellitus. It is a small molecule therapeutic candidate.
ISIS 113715 is developed by Ionis Pharmaceuticals, Inc., which trades under the ticker symbol IONS. The company sponsored the clinical studies of the drug in Type 2 Diabetes Mellitus. Development reached Phase 2 before the program's clinical trials were completed.
ISIS 113715 reached Phase 2 clinical development for Type 2 Diabetes Mellitus. It is an investigational drug and is not approved for any indication. Three trials have been completed, including two Phase 2 studies and one Phase 1 dermatologic study, and no trials are currently active.
ISIS 113715 was studied in three completed trials: NCT00455598, a Phase 2 placebo controlled dose escalation study in patients with Type 2 Diabetes Mellitus receiving sulfonylurea; NCT00330330, a Phase 2 study in previously untreated patients; and NCT00365781, a Phase 1 dermatologic study of subcutaneous injections. Total enrollment across these trials was 194 participants.
Yes. The ISIS 113715 clinical program included randomized, double blind, placebo controlled trials. The Phase 2 study NCT00455598 was a placebo controlled dose escalation trial in patients with Type 2 Diabetes Mellitus being treated with sulfonylurea, and the trials together enrolled 194 participants across sites in Poland, Romania, Russia, and the United States.