Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)

Mylan

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: Mylan's insulin glargine; Drug: Lantus®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02227862

MYL-GAI-3001

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 558 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Mylan's Insulin Glargine

Experimental group

Description:

Receive Mylan's Insulin Glargine plus insulin lispro.

Treatment:

Drug: Mylan's insulin glargine

Lantus®

Active Comparator group

Description:

Receive Lantus® plus insulin lispro

Treatment:

Drug: Lantus®