Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00804986 | A Study for Patients With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 247 | — | — | Dec 1, 2008 | Jan 1, 2010 | Jul 14, 2011 | 60 | United States, Austria +9 |
| NCT00853151 | A Study to Test the Combination of Two Different Kinds of Medications for the Treatment of Diabetes | PHASE1 | COMPLETED | 131 | — | — | Feb 1, 2009 | May 1, 2010 | Apr 13, 2012 | 29 | United States, Puerto Rico |
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 ...