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NCT02738151 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
A Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 929
- Enrollment target
- 20
- Study locations
NCT02738151: Completed Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
NCT02738151 is a Phase 4 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 929 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02738151, a Phase 4 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 929 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on: * Change in Fasting plasma glucose (FPG); * Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile; * Percentage of participants reaching HbA1c targets \<7% or ≤6.5%; * Percentage of participants reaching HbA1c targets \<7% or ≤6.5% without severe and/or confirmed hypoglycemia * Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia. To assess the safety in each treatment group. To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO). Percentage of participants requiring rescue therapy.
Primary Outcome
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period.
Conditions Studied
Interventions
- DRUG Insulin glargine, 300U/mL
- DRUG Insulin degludec, 100 U/mL
- DRUG Non-insulin anti-diabetic treatment
Study Locations (20)
California
- Investigational Site Number 840051 - Anaheim
- Investigational Site Number 840081 - Chino
- Investigational Site Number 840016 - Huntington Park
- Investigational Site Number 840002 - La Jolla
- Investigational Site Number 840091 - Los Angeles
- Investigational Site Number 840058 - Northridge
- Investigational Site Number 840021 - Palm Springs
- Investigational Site Number 840087 - Santa Ana
- Investigational Site Number 840030 - Torrance
- Investigational Site Number 840065 - Van Nuys
Florida
- Investigational Site Number 840075 - Bradenton
- Investigational Site Number 840076 - New Port Richey
- Investigational Site Number 840026 - Ocoee
- Investigational Site Number 840052 - Palm Harbor
- Investigational Site Number 840080 - Palm Harbor
- Investigational Site Number 840018 - Port Charlotte
Georgia
- Investigational Site Number 840071 - Lawrenceville
- Investigational Site Number 840085 - Roswell
Alabama
- Investigational Site Number 840038 - Sheffield
Arizona
- Investigational Site Number 840066 - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 929 participants |
| Start Date | 2016-05-19 |
| Est. Completion | 2017-08-15 |
| Phase | Phase 4 |
What the finished NCT02738151 record still lists
NCT02738151 is an interventional study that assigns participants to a tested intervention. The registered 929 participants enrollment target is mid-sized for trials with a published cap, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Insulin glargine, 300U/mL is the first listed.
NCT02738151 names 20 study sites across 5 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02738151 about?
NCT02738151 is a clinical study titled "Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist". Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresi...
What is the current status of trial NCT02738151?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 929 participants. The study started on 2016-05-19. Estimated completion is 2017-08-15.
What conditions does trial NCT02738151 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT02738151?
The interventions under investigation include: Insulin glargine, 300U/mL (DRUG), Insulin degludec, 100 U/mL (DRUG), Non-insulin anti-diabetic treatment (DRUG).
Who is sponsoring clinical trial NCT02738151?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02738151 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02738151's enrollment target sits among peer trials
929 39th of 348 higher than 310 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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.
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