Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (GEMELLI X)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility 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.
Sites / Locations
- Investigational Site Number 8400014
- Investigational Site Number 8400001
- Investigational Site Number 8400015
- Investigational Site Number 8400010
- Investigational Site Number 8400029
- Investigational Site Number 8400038
- Investigational Site Number 8400030
- Investigational Site Number 8400032
- Investigational Site Number 8400026
- Investigational Site Number 8400033
- Investigational Site Number 8400012
- Investigational Site Number 8400005
- Investigational Site Number 8400009
- Investigational Site Number 8400019
- Investigational Site Number 8400028
- Investigational Site Number 8400018
- Investigational Site Number 8400023
- Investigational Site Number 8400003
- Investigational Site Number 8400013
- Investigational Site Number 8400004
- Investigational Site Number 8400021
- Investigational Site Number 8400031
- Investigational Site Number 8400036
- Investigational Site Number 8400017
- Investigational Site Number 8400007
- Investigational Site Number 8400006
- Investigational Site Number 8400035
- Investigational Site Number 8400034
- Investigational Site Number 8400040
- Investigational Site Number 8400042
- Investigational Site Number 8400027
- Investigational Site Number 8400016
- Investigational Site Number 8400041
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Switching: NovoLog/SAR341402
Non-Switching: NovoLog
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.
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.