Clareo Health | Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mylan Inc.
With
Mylan GmbH
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®.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
