Status:
COMPLETED
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Lead Sponsor:
Mylan Inc.
Collaborating Sponsors:
Mylan GmbH
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 li...
Detailed Description
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 La...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT02227862
Start Date
June 1 2014
End Date
July 1 2016
Last Update
March 3 2022
Active Locations (162)
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1
Mylan Investigational Site
Bell Gardens, California, United States, 90201
2
Mylan Investigational Site
Fresno, California, United States, 93720
3
Mylan Investigational Site
Greenbrae, California, United States, 93720
4
Mylan Investigational Site
La Jolla, California, United States, 92037