Phase 3
Completed N=505
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Source: ClinicalTrials.gov NCT02294474 ↗Enrolled (actual)
505
Serious AEs
8.1%
Results posted
Jan 2018
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.92; -0.85 percentage of HbA1c
◆ Published Evidence
Established
25citations · ~3 / year
Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.
Summary
Primary Objective:
To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) 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. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c <7.0% and <=6.5%, fasting plasma glucose (FPG) and 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 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.92; -0.85 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26 |
42.3; 40.5; 27.3; 24.2 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
-0.62; -0.67 | — |
| SECONDARY Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 |
-1; -0.91 | — |
| SECONDARY Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26 |
-0.72; -0.23; 0.06; 0.11; 0.11; -0.1 | — |
| SECONDARY Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) |
68.4; 74.6; 2.4; 1.6; 60.1; 66.3 | — |
| SECONDARY Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions |
4; 3.6; 0.4; 1.6 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs) |
18.8; 14.5 | — |
Eligibility Criteria
Inclusion criteria
- Participants with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
- Signed written informed consent.
Exclusion criteria
- At screening visit, age under legal age of adulthood.
- HbA1c 10.0% at screening.
- Diabetes other than T2DM.
- Pregnancy and lactation.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control.
- Use of insulin pump in the 6 months before screening visit.
- Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
- Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
- Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
- Body mass index (BMI) >=40kg/m² at screening visit.
- 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 (NCT02294474) 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.