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

NCT03874715

CompletedPhase 3

Sponsor: Sanofi

Conditions: Type 1 Diabetes Mellitus

Interventions: Insulin Aspart SAR341402, Insulin Aspart, Insulin glargine U100

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (33)
  • Concord, California, United States
  • Temecula, California, United States
  • Ventura, California, United States
  • Aurora, Colorado, United States
  • Waterbury, Connecticut, United States
  • Doral, Florida, United States
  • Miami, Florida, United States
  • New Port Richey, Florida, United States
  • Ocoee, Florida, United States
  • Palm Harbor, Florida, United States
  • Atlanta, Georgia, United States
  • Columbus, Georgia, United States
  • Roswell, Georgia, United States
  • Crystal Lake, Illinois, United States
  • Des Moines, Iowa, United States
  • Lexington, Kentucky, United States
  • Baltimore, Maryland, United States
  • Rockville, Maryland, United States
  • Waltham, Massachusetts, United States
  • Flint, Michigan, United States
  • Kansas City, Missouri, United States
  • Washington, Missouri, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Morehead City, North Carolina, United States
  • Rocky Mount, North Carolina, United States
  • Jefferson City, Tennessee, United States
  • Dallas, Texas, United States
  • El Paso, Texas, United States
  • + 3 more on CT.gov