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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: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT03434119 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 241 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
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 |
Why NCT03434119 stopped before completion
NCT03434119 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine (HOE901) is the first listed.
NCT03434119 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03434119's enrollment target sits among peer trials
241 1272nd of 2000 higher than 728 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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