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NCT03434119 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
NCT03434119 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 241 participants.
The verdict
NCT03434119, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Insulin glargine (HOE901)
- DRUG Background therapy
- DRUG Insulin glargine/Lixisenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2019-01-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03434119
The ClinicalTrials.gov registry entry for NCT03434119 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine (HOE901) is the first listed.
NCT03434119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03434119 about?
NCT03434119 is a clinical study titled "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". 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, ...
What is the current status of trial NCT03434119?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2018-02-20. Estimated completion is 2019-01-07.
What interventions are being tested in trial NCT03434119?
The interventions under investigation include: Insulin glargine (HOE901) (DRUG), Background therapy (DRUG), Insulin glargine/Lixisenatide (DRUG).
Who is sponsoring clinical trial NCT03434119?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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