Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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 to 24 weeks

Key facts

Study ID

NCT02227875

Run by

Mylan Inc.

People needed

560

Starts

2014-08-01

Expected to finish

2015-12-01

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 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.

You may not qualify if…

• 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.

Where it is running

• Mylan Investigational Site — Bell Gardens, California, United States
• Mylan Investigational Site — Fresno, California, United States
• Mylan Investigational Site — Greenbrae, California, United States
• Mylan Investigational Site — Long Beach, California, United States
• Mylan Investigational Site — Los Angeles, 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 — Orange, California, United States
• Mylan Investigational Site — Palm Springs, California, United States
• Mylan Investigational Site — Spring Valley, California, United States
• Mylan Investigational Site — Tustin, California, United States
• Mylan Investigational Site — Walnut Creek, California, United States
• Mylan Investigational Site — West Hills, 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 — 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 — Pembroke Pines, Florida, United States
• Mylan Investigational Site — Port Charlotte, Florida, United States
• Mylan Investigational Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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