Trials / Completed
CompletedNCT03874715
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
The study duration per participant was less than 19 weeks (for participants who did not require the run-in period) and less than 31 weeks (for participants who require the run-in period).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin Aspart SAR341402 | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| DRUG | Insulin Aspart | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| DRUG | Insulin glargine U100 | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
Timeline
- Start date
- 2019-03-11
- Primary completion
- 2020-07-08
- Completion
- 2020-07-08
- First posted
- 2019-03-14
- Last updated
- 2024-04-17
- Results posted
- 2023-07-21
Locations
33 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03874715. Inclusion in this directory is not an endorsement.