Phase 3
Completed N=597
Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03211858 ↗
Enrolled (actual)
597
Serious AEs
10.9%
Results posted
Aug 2019
Primary outcomePrimary: Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 — -0.38; -0.30 percentage of HbA1c
◆ Published Evidence
Emerging
6citations · ~1 / year
Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin.
Summary
Primary Objective:
To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.
Secondary Objectives:
* To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study.
* To assess the relationship of AIAs with efficacy and safety.
* To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c).
* To assess safety of SAR341402 and NovoLog/NovoRapid.
Linked Publications
-
Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 |
-0.38; -0.30 | — |
| SECONDARY Change in HbA1c From Baseline to Week 52 |
-0.25; -0.26 | — |
| SECONDARY Percentage of Participants With HbA1c <7% at Week 26 and Week 52 |
16.6; 14.5; 19.6; 18.2 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 |
-0.49; -0.17; -0.10; -0.34 | — |
| SECONDARY Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52 |
-0.34; -0.53; 0.12; -0.18 | — |
| SECONDARY Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52 |
0.50; 0.65; 0.18; 0.12; 0.36; 0.66 | — |
| SECONDARY Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point |
-0.62; -0.50; -0.39; -0.30; -0.60; -0.60 | — |
| SECONDARY Number of Participants With at Least One Hypoglycemic Event |
291; 285; 12; 10; 264; 251 | — |
| SECONDARY Number of Hypoglycemia Events Per Participant-Year |
73.33; 69.71; 0.14; 0.10; 40.36; 36.37 | — |
| SECONDARY Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions |
3.7; 3.7; 0.7; 1.4; 5.6; 7.1 | — |
| SECONDARY Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample |
48.0; 52.4; 54.7; 58.2 | — |
| SECONDARY Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs) |
23.0; 28.4; 4.2; 5.1; 16.9; 20.5 | — |
Eligibility Criteria
Inclusion criteria
- Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with
- NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND
- insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit.
Exclusion criteria
- At screening visit, age under legal age of adulthood.
- HbA1c ) 10% at screening.
- Less than 1 year on continuous insulin treatment.
- Use of insulin pump in the last 3 months before screening visit.
- Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.
- Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening.
- Participants with T2DM:
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit.
- Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline).
- At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants with T2DM.
- Use of insulin other than:
- insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as part of a multiple injection regimen in the last 6 months before screening visit, OR
- insulin detemir 100 U/mL in the 12 months before screening visit and NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before screening visit as part of a multiple injection regimen.
- Status post pancreatectomy.
- Status post pancreas and/or islet cell transplantation.
- Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit.
- History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 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.
- Pregnant or breastfeeding women.
- Women of childbearing potential not protected by highly effective method(s) of birth control.
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 (NCT03211858) 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.