Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
taspoglutide · 12 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | - |
| taspoglutide | EXPERIMENTAL | - |
| pioglitazone | ACTIVE_COMPARATOR | - |
| taspoglutide 10mg | EXPERIMENTAL | taspoglutide 10mg sc weekly |
| taspoglutide 10mg/20mg | EXPERIMENTAL | taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| insulin glargine | ACTIVE_COMPARATOR | insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment |
| taspoglutide 10 mg | EXPERIMENTAL | taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment |
| taspoglutide 10 mg/20 mg | EXPERIMENTAL | taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment |
| Sitagliptin | ACTIVE_COMPARATOR | Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses. |
| Taspoglutide up-titrated to 20 mg | EXPERIMENTAL | Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses. |
| taspoglutide 10mg sc | EXPERIMENTAL | - |
| taspoglutide 10mg/20mg sc | EXPERIMENTAL | - |
| exenatide | ACTIVE_COMPARATOR | - |
| Taspoglutide 20mg | EXPERIMENTAL | sc weekly |
| Taspoglutide 20mg-30mg | EXPERIMENTAL | sc weekly |
| Taspoglutide 20mg-40mg | EXPERIMENTAL | sc weekly |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | sc weekly |
| taspoglutide | DRUG | 10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly |
| pioglitazone | DRUG | 30mg po once daily for 4 weeks, followed by 45mg once daily |
| insulin glargine | DRUG | starting dose 10 IU daily |
| metformin | DRUG | As prescribed |
| Placebo (matching sitagliptin) | DRUG | Once daily oral administration of placebo (matching sitagliptin). |
| Placebo (matching taspoglutide) | DRUG | Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide). |
| Sitagliptin | DRUG | Once daily oral administration of 100 mg of sitagliptin. |
| exenatide | DRUG | 5mg twice daily for 4 weeks followed by 10mg twice daily |
| Taspoglutide 20mg | DRUG | sc weekly |
| Taspoglutide 20mg-30mg | DRUG | sc weekly |
| Taspoglutide 20mg-40mg | DRUG | sc weekly |
Inclusion Criteria: * adult patients, \>18 years of age * diabetes mellitus type 2 * HbA1c \>/=6.5% and \</=10% at screening * BMI \>/=23kg/m2 * cardiovascular disease with onset \>/=1 month prior to screening Exclusion Criteria: * diagnosis or history of type 1 diabetes or secondary forms of dia...
Taspoglutide was developed for the treatment of Diabetes Mellitus Type 2. It was studied in adults whose blood glucose was inadequately controlled, including patients on metformin monotherapy and patients with type 2 diabetes and cardiovascular disease. All of its clinical trials have been completed.
Taspoglutide targets GLP1R, the glucagon-like peptide-1 receptor, and acts as an agonist at that receptor. GLP1R agonism is the mechanism explored in its clinical program for glycemic control in type 2 diabetes. Taspoglutide is described as a small molecule.
Taspoglutide was developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical trial program evaluating the compound in type 2 diabetes, including the Phase 3 studies and an earlier Phase 1 study.
Taspoglutide reached Phase 3 development for Diabetes Mellitus Type 2. It is an investigational agent and is not approved. Its registered trials are all completed, with no active studies, and the program includes 12 completed trials enrolling a total of 7,322 participants.
Completed taspoglutide trials include NCT01018173, a Phase 3 study in patients with inadequately controlled type 2 diabetes and cardiovascular disease that enrolled 2,118 participants, and NCT00909597, a Phase 3 study comparing taspoglutide with pioglitazone in 756 patients. NCT00823992 tested it versus placebo in obese patients with type 2 diabetes on metformin.