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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01894568 | A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment | PHASE3 | COMPLETED | 388 | — | — | Jul 1, 2013 | Apr 1, 2015 | Mar 15, 2019 | 31 | Japan, South Korea +1 |
Hemoglobin A1c (HbA1c) is a test that measures a participant'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) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \[LDL-C\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
| Arm | Type | Description |
|---|---|---|
| Insulin Peglispro | EXPERIMENTAL | Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs). |
| Insulin Glargine | ACTIVE_COMPARATOR | Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs. |
| Name | Type | Description |
|---|---|---|
| Insulin Peglispro | DRUG | Administered SC using a prefilled pen. |
| Insulin Glargine | DRUG | Administered SC using a prefilled pen |
| Oral Antihyperglycemic Medications (OAMs) | DRUG | Administered orally |
Inclusion Criteria: * Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin * Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening * Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to centr...