Phase 3
N=210
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03874715 ↗Enrolled (actual)
210
Serious AEs
4.8%
Results posted
Jul 2023
Primary outcome: Primary: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) — 8960; 7190 picograms*hour per milliliter (pg*h/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin Aspart SAR341402 (Drug); Insulin Aspart (Drug); Insulin glargine U100 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) |
8960; 7190 | — |
| PRIMARY Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) |
6720; 7260 | — |
| PRIMARY Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) |
11800; 3330 | — |
| SECONDARY Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs) |
8; 11; 0; 1; 8; 10 | — |
| SECONDARY Number of Participants With at Least One Hypoglycemic Event |
95; 105; 6; 4; 89; 98 | — |
| SECONDARY Number of Hypoglycemic Events Per Participant-year |
103.18; 97.09; 0.76; 0.38; 64.29; 63.54 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
25; 47; 5; 5 | — |
| SECONDARY Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) |
1.33; 1.00 | — |
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).
Eligibility Criteria
Inclusion criteria
- Participants with T1DM.
- Participants on continuous insulin treatment for at least 12 months prior to screening.
- Participants exclusively on a multiple (greater than or equal to 3) daily injection insulin analogue regimen using:
- NovoLog as mealtime insulin for at least 12 weeks prior to screening and
- Insulin glargine (100 units per milliliter [U/mL]) as basal insulin for at least 12 weeks prior to screening. Note: Participants not meeting this criterion could also qualify, provided that they completed the run-in period during which NovoLog and Lantus was administered so that, at the time of randomization, the participants had been on NovoLog and insulin glargine (100 U/mL) for at least 12 weeks (including any potential pre-screening administration).
- Glycated hemoglobin (HbA1c) less than or equal to 10 percent (%) (85.79 millimoles per mole) at screening.
- Body mass index less than or equal to 35 kilograms per meter square (kg/m^2) at screening.
Exclusion criteria
- Pancreatectomy and/or islet cell transplantation.
- Clinically significant laboratory findings, as defined by the protocol.
- Known presence of factors that interfered with the HbA1c measurement.
- History of severe hypoglycemia required emergency room admission or hospitalization within 3 months prior to screening.
- Hospitalization for recurrent diabetic ketoacidosis within 3 months prior to screening.
- Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
- Use of glucose lowering treatments other than the multiple dose injections and basal insulin regimen (including use of insulin pump therapy), within 12 weeks prior to screening.
- Participants had received systemic glucocorticoids for one week or more within 3 months prior to screening (topical, nasal spray, inhaled or intra-articular applications are allowed).
- Participants had received systemic immunosuppressive agents within 6 months prior to screening.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03874715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.