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

Completed · Phase 3

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT02227862

Run by

Mylan Inc.

People needed

558

Starts

2014-06-01

Expected to finish

2016-07-01

Last updated by the study team

2022-03-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Mylan Investigational Site — Fresno, California, United States
• Mylan Investigational Site — Greenbrae, California, United States
• Mylan Investigational Site — La Jolla, California, United States
• Mylan Investigational Site — La Mesa, California, United States
• Mylan Investigational Site — Long Beach, California, United States
• Mylan Investigational Site — Los Gatos, California, United States
• Mylan Investigational Site — Mission Hills, California, United States
• Mylan Investigational Site — National City, California, United States
• Mylan Investigational Site — Northridge, California, United States
• Mylan Investigational Site — Tustin, California, United States
• Mylan Investigational Site — Walnut Creek, California, United States
• Mylan Investigational Site — Bradenton, Florida, United States
• Mylan Investigational Site — Cooper City, Florida, United States
• Mylan Investigational Site — Hialeah, Florida, United States
• Mylan Investigational Site — Hollywood, Florida, United States
• Mylan Investigational Site — Miami, Florida, United States
• Mylan Investigational Site — Miami, Florida, United States
• Mylan Investigational Site — New Port Richey, Florida, United States
• Mylan Investigational Site — Palm Harbor, Florida, United States
• Mylan Investigational Site — West Palm Beach, Florida, United States
• Mylan Investigational Site — Atlanta, Georgia, United States
• Mylan Investigational Site — Columbus, Georgia, United States
• Mylan Investigational Site — Honolulu, Hawaii, United States
• Mylan Investigational Site — Idaho Falls, Idaho, United States
• Mylan Investigational Site — Bell Gardens, California, United States

Full record on ClinicalTrials.gov

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