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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06739122 | A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS) | PHASE3 | RECRUITING | 55 | — | — | Jan 10, 2025 | Dec 1, 2027 | May 12, 2026 | 51 | United States, Argentina +1 |
| NCT02963766 | A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes | PHASE3 | COMPLETED | 154 | — | — | Dec 29, 2016 | Jan 12, 2022 | Jul 1, 2022 | 61 | United States, Brazil +9 |
| NCT01621178 | A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) | PHASE3 | COMPLETED | 577 | — | — | Jul 1, 2012 | Dec 1, 2016 | Sep 19, 2019 | 89 | United States, Brazil +7 |
| NCT01624259 | A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes | PHASE3 | COMPLETED | 599 | — | — | Jun 1, 2012 | Nov 1, 2013 | Oct 9, 2014 | 57 | United States, Czechia +8 |
| NCT02973100 | A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy | PHASE2 | COMPLETED | 318 | — | — | Dec 1, 2016 | Aug 14, 2017 | Sep 23, 2019 | 66 | United States, Czechia +4 |
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.
Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
| Arm | Type | Description |
|---|---|---|
| Dulaglutide | EXPERIMENTAL | Participants will receive dulaglutide subcutaneously (SC) |
| Placebo/0.75 milligram (mg) Dulaglutide | EXPERIMENTAL | Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE). |
| 0.75 mg Dulaglutide | EXPERIMENTAL | Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE. |
| 1.5 mg Dulaglutide | EXPERIMENTAL | Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE. |
| Insulin glargine | ACTIVE_COMPARATOR | Insulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| 1.5 mg LY2189265 | EXPERIMENTAL | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks |
| Liraglutide | ACTIVE_COMPARATOR | Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks |
| Dulaglutide 4.5mg | EXPERIMENTAL | 4.5mg of Dulaglutide administered subcutaneously (SC) |
| Dulaglutide 3.0mg | EXPERIMENTAL | 3.0mg of Dulaglutide administered SC |
| Dulaglutide 1.5mg | ACTIVE_COMPARATOR | 1.5mg of Dulaglutide administered SC |
| Placebo | PLACEBO_COMPARATOR | Placebo administered SC |
| Name | Type | Description |
|---|---|---|
| Dulaglutide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Insulin glargine | DRUG | Administered SC |
| Insulin lispro | DRUG | Administered SC |
| LY2189265 | DRUG | Administered SC |
| Liraglutide | DRUG | Administered SC |
| Metformin | DRUG | - |
Inclusion Criteria: * Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile Exclusion...