Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

• Status: Completed
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion criteria:

• Participants with type 1 diabetes mellitus.

• Participants on continuous insulin treatment for at least 12 months prior to screening.

• Participants exclusively on a multiple (≥3) daily injection insulin analogue regimen using:

• NovoLog as mealtime insulin for at least 12 weeks prior to screening and

• Insulin glargine (100 U/mL) as basal insulin for at least 12 weeks prior to screening Note: Participants not meeting this criterion may also qualify, provided that they complete the run-in period during which NovoLog and Lantus will be administered so that, at the time of randomization, the participants have been on NovoLog and insulin glargine (100 U/mL) for at least 12 weeks (including any potential pre-screening administration).

• Glycated hemoglobin (HbA1c) below 10% (85.79 mmol/mol) (inclusive) at screening.

• Body mass index (BMI) ≤35 kg/m² at screening.

Exclusion criteria:

• Pancreatectomy and/or islet cell transplantation.

• Clinically significant laboratory findings, as defined by the protocol.

• Known presence of factors that interfere with the HbA1c measurement.

• History of severe hypoglycemia requiring 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 (MDI) and basal insulin regimen (including use of insulin pump therapy), within 12 weeks prior to screening.

• Participants having 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 having received systemic immunosuppressive agents within 6 months prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.