Phase 3
Completed N=558
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Source: ClinicalTrials.gov NCT02227862 ↗Enrolled (actual)
558
Serious AEs
7.2%
Results posted
Mar 2020
Primary outcomePrimary: Change in HbA1c From Baseline to 24 Weeks — 0.14; 0.11 percent
◆ Published Evidence
Emerging
4citations · ~1 / year
Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.
Summary
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.
Linked Publications
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Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to 24 Weeks |
0.14; 0.11 | — |
| SECONDARY Summary of Actual and Change From Baseline in HbA1c |
0.12; 0.09; 0.2; 0.25 | — |
| SECONDARY Change From Baseline in FPG Over Time |
-0.81; 0.09; 0.23; 0.43 | — |
| SECONDARY Change From Baseline in 8-point SMBG Profile Over Time |
0.038; -0.095; -0.082; -0.082 | — |
| SECONDARY Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time |
0.0203; 0.0127; 0.0278; 0.0138 | — |
| SECONDARY Rate of Hypoglycemic Events Per 30 Days Over Time |
-5.162; -4.93; -6.241; -5.765 | — |
| SECONDARY Hypoglycemia Occurrence |
273; 269; 11; 13; 249; 249 | — |
| SECONDARY Occurrence of Local and Systematic Reactions |
3; 4; 2; 2 | — |
| SECONDARY Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time |
-0.3063; 0.3592; -0.9591; -1.0634 | — |
| SECONDARY Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time |
-0.215; 0.157; -0.896; -1.233 | — |
| SECONDARY Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time |
-0.363; 0.27; -1.132; -1.21 | — |
| SECONDARY Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time |
-0.265; 0.055; -1.060; -1.367 | — |
| SECONDARY Proportion of Patients With HbA1c < 7% |
73; 84; 65; 61 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with an established diagnosis of T1DM per ADA 2014 criteria
- Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
- Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.
- Hemoglobin ≥9.0 g/dL at screening.
Exclusion Criteria
- History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
- History of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
- History of use of a regular immunomodulator therapy in the 1 year prior to screening.
- History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I), as judged by the investigator.
- History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
- Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.
- History of drug or alcohol dependence or abuse during the 1 year prior to screening.
Data sourced from ClinicalTrials.gov (NCT02227862) 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.