Status:
COMPLETED
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Lead Sponsor:
Mylan Inc.
Collaborating Sponsors:
Mylan GmbH
Conditions:
Type 2 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 (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline t...
Detailed Description
This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an es...
Eligibility Criteria
Inclusion
- Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:
- Diagnosis established 1 year prior to screening
- Insulin-naïve OR
- On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening
- Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).
- Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.
- Hemoglobin ≥9.0 g/dL at screening
- Glycosylated hemoglobin (HbA1c) of \<10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.
Exclusion
- History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions.
- History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.
- Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.
- Regular use of immune-modulator 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 episode of hyperglycemic hyperosmolar coma 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.
- Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT02227875
Start Date
August 1 2014
End Date
December 1 2015
Last Update
March 3 2022
Active Locations (120)
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1
Mylan Investigational Site
Chandler, Arizona, United States, 85224
2
Mylan Investigational Site
Bell Gardens, California, United States, 90201
3
Mylan Investigational Site
Fresno, California, United States, 93720
4
Mylan Investigational Site
Greenbrae, California, United States, 94904