Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2428757 · 2 trials · 1 indication
LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.
Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise \[D\&E\]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).
| Arm | Type | Description |
|---|---|---|
| 0.5 mg LY2428757 | EXPERIMENTAL | Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| 2.0 mg LY2428757 | EXPERIMENTAL | Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| 6.2 mg LY2428757 | EXPERIMENTAL | Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| 12.0 mg LY2428757 | EXPERIMENTAL | Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| 17.6 mg LY2428757 | EXPERIMENTAL | Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| Placebo | PLACEBO_COMPARATOR | Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. |
| LY2428757 plus TT223 3 milligrams (mg) | EXPERIMENTAL | Weekly LY2428757 plus 3 milligrams (mg) daily TT223 |
| LY2428757 plus TT223 2mg | EXPERIMENTAL | Weekly LY2428757 plus 2 mg daily TT223 |
| LY2428757 plus placebo | EXPERIMENTAL | Weekly LY2428757 plus daily TT223 placebo |
| Placebo plus Placebo | PLACEBO_COMPARATOR | Weekly LY2428757 placebo plus daily TT223 placebo |
| Name | Type | Description |
|---|---|---|
| LY2428757 | DRUG | Once weekly for 12 weeks as a subcutaneous injection. |
| Placebo | DRUG | 1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection. |
| TT223 | DRUG | subcutaneous injection once a day for 4 weeks |
| Placebo for LY2428757 | DRUG | subcutaneous injection 1 time a week for 5 weeks |
| Placebo for TT223 | DRUG | subcutaneous injection once a day for 4 weeks |
Inclusion Criteria: * Have type 2 diabetes mellitus for at least 6 months prior to entering the trial. * Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening. * Have a glycosylated fraction of hemoglobin ...
LY2428757 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 been studied in completed clinical trials involving patients with this condition.
LY2428757 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is an investigational small molecule intended for the treatment of Type 2 Diabetes Mellitus.
LY2428757 is in Phase 2 clinical development for Type 2 Diabetes Mellitus. It has completed two clinical trials, including a Phase 2 study and a Phase 1 study, with a total of 378 participants enrolled across multiple countries.
LY2428757 has been studied in two completed clinical trials. NCT00804986 was a Phase 2 study with 247 participants, and NCT00853151 was a Phase 1 study with 131 participants, both involving patients with Type 2 Diabetes Mellitus.
LY2428757 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has completed clinical trials but remains under investigation and has not been approved for commercial use.