Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
- Registration Number
- NCT02227862
- Lead Sponsor
- Mylan Inc.
- Brief 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.
- Detailed Description
This trial is a multicenter, open-label, randomized, parallel-group trial in patients with Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 558
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lantus® Lantus® Receive Lantus® plus insulin lispro Mylan's Insulin Glargine Mylan's insulin glargine Receive Mylan's Insulin Glargine plus insulin lispro.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to 24 Weeks 24 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in FPG Over Time 24 and 52 weeks Summary of Actual and Change From Baseline in HbA1c 24 and 52 weeks Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time 24 and 52 weeks Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time 24 and 52 weeks Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time 24 and 52 weeks Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time 24 and 52 weeks Occurrence of Local and Systematic Reactions 52 weeks Change From Baseline in 8-point SMBG Profile Over Time 24 and 52 weeks Rate of Hypoglycemic Events Per 30 Days Over Time 24 and 52 weeks Hypoglycemia Occurrence 52 weeks Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time 24 and 52 weeks Proportion of Patients With HbA1c < 7% 24 and 52 weeks
Trial Locations
- Locations (2)
Texas Diabetes & Endocrinology
🇺🇸Round Rock, Texas, United States
Mylan Investigational Site
🇬🇧Swansea, United Kingdom