THIS TRIAL IS NOW CLOSED
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
Sponsor: Mylan Inc.
Contact: Anne Bergin, 541-706-6597 or email@example.com
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.
- 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.
- 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.
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