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

Investigator:  Mary F Carroll, MD

Status: Recruiting

Phase: 3

Sponsor: Mylan Inc.

Contact: Anne Bergin, 541-706-6597 or

Location: Bend, Oregon (Central Oregon)

Purpose:  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.

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.

See this trial at

For general inquiries, please contact the BMC Research Department at or 877-692-8338.

Back to Clinical Research


Post Comment