Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GK Activator · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GK Activator (2) | DRUG | 25-200mg po bid for 20 weeks |
| Metformin | DRUG | As prescribed, in patients who were in study BM18249 |
| Placebo | DRUG | po bid |
| Glyburide | DRUG | 10-20mg po daily |
| Simvastatin | DRUG | 80mg po |
Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening. Exclusion Criteria: * type 1 diabetes mellitus; * treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 m...
GK Activator is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with Type 2 diabetes to evaluate its safety and efficacy.
GK Activator is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the drug's potential in treating Type 2 Diabetes Mellitus.
GK Activator is currently in Phase 2 clinical development. It has completed seven clinical trials, including one Phase 2 study and several Phase 1 studies. The drug remains investigational and has not received FDA approval. All completed trials focused on patients with Type 2 Diabetes Mellitus.
GK Activator has been studied in seven completed clinical trials. Key trials include NCT00366379, a Phase 2 dose-titration study in 127 patients, and NCT00368368, a Phase 1 renal impairment study. Other trials include drug-drug interaction studies with simvastatin (NCT00377442) and glyburide (NCT00388986).
Yes, GK Activator is the same drug as GK Activator (2). Clinical trial records refer to the drug as GK Activator (2) in study titles, such as NCT00366379 and NCT00368368. Both names refer to the same investigational compound being developed by Roche for Type 2 Diabetes Mellitus.