Last reviewed · How we verify
Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (LixiLan-D)
Primary Objective: * To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population. * To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians). Secondary Objective: * To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated. * To assess the change in daily insulin glargine dose within each ethnic/racial subgroup. * To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | PHASE3 |
| Status | TERMINATED |
| Enrolment | 241 |
| Start date | Tue Feb 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Jan 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Insulin glargine/Lixisenatide
- Insulin glargine (HOE901)
- Background therapy
Countries
United States