Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4998452 · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. |
| RO4998452 10mg | EXPERIMENTAL | During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452. |
| RO4998452 2.5mg | EXPERIMENTAL | During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452. |
| RO4998452 20mg | EXPERIMENTAL | During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452. |
| RO4998452 40mg | EXPERIMENTAL | During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452. |
| RO4998452 5mg | EXPERIMENTAL | During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452. |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| 1 (normal) | EXPERIMENTAL | - |
| 2 (mild) | EXPERIMENTAL | - |
| 3 (moderate) | EXPERIMENTAL | - |
| 4 (severe) | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | EXPERIMENTAL | - |
| 7 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | po daily for 12 weeks |
| RO4998452 | DRUG | 2.5mg po daily for 12 weeks |
Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes, diagnosed for \>=3 months; * either treated with diet, exercise and stable metformin, or with diet and exercise alone. Exclusion Criteria: * type 1 diabetes mellitus; * currently or within 2 months prior to screening tre...
RO4998452 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is in Phase 2 clinical development and has been studied in patients with this condition across multiple trials.
RO4998452 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of this investigational drug in patients with Type 2 Diabetes Mellitus.
RO4998452 is in Phase 2 clinical development. It has completed four clinical trials, including a Phase 2 dose-finding study, and is not yet approved by regulatory authorities.
RO4998452 has completed four clinical trials: NCT00682097, a Phase 1 multiple ascending dose study; NCT00800176, a Phase 2 dose-finding study; NCT00933972, a Phase 1 study in patients with renal impairment; and NCT01044017, a Phase 1 single dose study. All trials enrolled patients with Type 2 Diabetes Mellitus.
No alternative names for RO4998452 have been identified in the available information. It is referred to solely by its code name RO4998452 in clinical trial records.