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NCT05114590 · ClinicalTrials.gov registry record · Phase 4
Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 124
- Enrollment target
NCT05114590 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 124 participants.
The verdict
NCT05114590, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 124 participants
- Enrollment target
Study Summary
The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs \[OADs\] with or without a glucagon-like peptide 1 receptor agonist \[GLP1 RA\]), as measured by continuous glucose monitoring (CGM). The total study duration per participant was approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts were scheduled. * A screening period of up to 2 weeks * A run-in period of up to 2 weeks, including the baseline period * A 16-week, open-label treatment period * A 2-week post-treatment safety follow-up period
Interventions
- DRUG Insulin glargine/Lixisenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2023-04-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05114590
The ClinicalTrials.gov registry entry for NCT05114590 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 124 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 1 intervention - of which Insulin glargine/Lixisenatide is the first listed.
NCT05114590 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05114590 about?
NCT05114590 is a clinical study titled "Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus". The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs \[OADs\] wi...
What is the current status of trial NCT05114590?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 124 participants. The study started on 2022-01-27. Estimated completion is 2023-04-14.
What interventions are being tested in trial NCT05114590?
The interventions under investigation include: Insulin glargine/Lixisenatide (DRUG).
Who is sponsoring clinical trial NCT05114590?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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