Phase 3
Completed N=507
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Source: ClinicalTrials.gov NCT02273180 ↗Enrolled (actual)
507
Serious AEs
7.7%
Results posted
Jan 2018
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.42; -0.47 percentage of HbA1c
◆ Published Evidence
Established
33citations · ~4 / year
Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study.
Summary
Primary Objective:
To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.
To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.
To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.
To assess safety of SAR342434 and Humalog.
Linked Publications
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Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.42; -0.47 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0% at Week 26 |
22.5; 21.7 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
-0.46; -0.62 | — |
| SECONDARY Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 |
-0.23; -0.49 | — |
| SECONDARY Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 |
-0.46; 0.19; 0.14; -0.26; 0.48; 0.56 | — |
| SECONDARY Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year |
90.71; 92.7; 0.73; 0.28; 29.36; 31.37 | — |
| SECONDARY Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions |
6; 6.3; 1.2; 1.2 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs) |
22.6; 24.2 | — |
Eligibility Criteria
Inclusion criteria
- Participants with T1DM diagnosed for at least 12 months and had been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit.
- Written informed consent.
Exclusion criteria
- At screening visit, age under legal age of adulthood.
- HbA1c 10% at screening.
- Diabetes other than T1DM.
- Status post pancreatectomy.
- Status post pancreas and/or islet cell transplantation.
- Pregnancy and lactation.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control.
- Less than 1 year on continuous insulin treatment.
- Use of insulin pump in the last 6 months before screening visit.
- Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit.
- Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed.
- Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02273180) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.