Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Public ClinicalTrials.gov record NCT03874715. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: * To compare the effects of alternating administration of SAR341402 and NovoLog with continuous use of NovoLog on immunogenicity. * To evaluate the safety of alternating administration of SAR341402 and NovoLog versus continuous use of NovoLog. * To compare other PK parameters between the two treatment arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog).
Study identification
- NCT ID
- NCT03874715
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2019 (Actual)
- Primary completion
- Jul 8, 2020 (Actual)
- Completion
- Jul 8, 2020 (Actual)
- Last update posted
- Apr 17, 2024
2019 – 2020
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400014 | Concord | California | 94520 | — |
| Investigational Site Number 8400001 | Temecula | California | 92591 | — |
| Investigational Site Number 8400015 | Ventura | California | 93003 | — |
| Investigational Site Number 8400010 | Aurora | Colorado | 80045 | — |
| Investigational Site Number 8400029 | Waterbury | Connecticut | 06708-3346 | — |
| Investigational Site Number 8400038 | Doral | Florida | 33166 | — |
| Investigational Site Number 8400030 | Miami | Florida | 33165 | — |
| Investigational Site Number 8400032 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 8400026 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8400033 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 8400012 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 8400005 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 8400009 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 8400019 | Crystal Lake | Illinois | 60012 | — |
| Investigational Site Number 8400028 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 8400018 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 8400023 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 8400003 | Rockville | Maryland | 20852-4267 | — |
| Investigational Site Number 8400013 | Waltham | Massachusetts | 02453 | — |
| Investigational Site Number 8400004 | Flint | Michigan | 48532 | — |
| Investigational Site Number 8400021 | Kansas City | Missouri | 64111 | — |
| Investigational Site Number 8400031 | Washington | Missouri | 63090 | — |
| Investigational Site Number 8400036 | Omaha | Nebraska | 68114 | — |
| Investigational Site Number 8400017 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 8400007 | New York | New York | 10001 | — |
| Investigational Site Number 8400006 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 8400035 | Rocky Mount | North Carolina | 27804 | — |
| Investigational Site Number 8400034 | Jefferson City | Tennessee | 37760 | — |
| Investigational Site Number 8400040 | Dallas | Texas | 75235 | — |
| Investigational Site Number 8400042 | El Paso | Texas | 79935 | — |
| Investigational Site Number 8400027 | Houston | Texas | 77079 | — |
| Investigational Site Number 8400016 | Mesquite | Texas | 75149 | — |
| Investigational Site Number 8400041 | Waco | Texas | 76710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03874715, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03874715 live on ClinicalTrials.gov.