Status:
COMPLETED
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 contin...
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03874715
Start Date
March 11 2019
End Date
July 8 2020
Last Update
April 17 2024
Active Locations (33)
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1
Investigational Site Number 8400014
Concord, California, United States, 94520
2
Investigational Site Number 8400001
Temecula, California, United States, 92591
3
Investigational Site Number 8400015
Ventura, California, United States, 93003
4
Investigational Site Number 8400010
Aurora, Colorado, United States, 80045