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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01435616 | A Study in Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 1,538 | — | — | Nov 1, 2011 | Jan 1, 2014 | Apr 13, 2018 | 167 | United States, Argentina +21 |
HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
| Arm | Type | Description |
|---|---|---|
| LY2605541 | EXPERIMENTAL | LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks |
| Glargine | ACTIVE_COMPARATOR | Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks |
| Name | Type | Description |
|---|---|---|
| Glargine | DRUG | - |
| LY2605541 | DRUG | - |
Inclusion Criteria: * Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study * Have been receiving at least 2 OAMs for at least 3 months before entering the study * Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening * Are cap...