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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Aspart; Drug: Insulin glargine U100; Drug: Insulin Aspart SAR341402

Study type: Interventional

Funder types: Industry

Identifiers

NCT03874715

EFC15178

U1111-1197-7811 (Other Identifier)

136342 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

210 participants in 2 patient groups

Switching: NovoLog/SAR341402

Experimental group

Description:

Participants self-administered subcutaneous (SC) injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 units per milliliters \[U/mL\]) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin.

Treatment:

Drug: Insulin Aspart SAR341402

Drug: Insulin glargine U100

Drug: Insulin Aspart

Non-Switching: NovoLog

Active Comparator group

Description:

Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin.

Treatment:

Drug: Insulin glargine U100

Drug: Insulin Aspart