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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: Completed Phase 4 study, sponsored by Sanofi.
NCT05114590 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 124 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The percentage of time spent in the glycemic target range of 70 to 180 mg/dL was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements. Baseline is defined as the first 14 evaluable days of evaluable continuous glucose monitoring (CGM) data prior to first day of treatment. CGM compliance is defined as 1) at least 8 out of 14 days (not necessarily consecutive) have 100% of evaluabl
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 |
What the finished NCT05114590 record still lists
NCT05114590 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Insulin glargine/Lixisenatide is the first listed.
NCT05114590 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05114590's enrollment target sits among peer trials
124 656th of 2000 higher than 1,339 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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