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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: Mylan GmbH
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc

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.