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INSTRIDE 1 Study to Compare the Efficacy and Safety of Mylan’s Insulin Glargine with Lantus in People with Type 1 Diabetes

Published: 10/27/14
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Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page.

Clinical Identifier: NCT02227862

In the INSTRIDE 1 clinical trial, Mylan, Inc. is testing whether its once-daily “biosimilar” insulin glargine product is comparable to Sanofi’s Lantus (insulin glargine) when administered in combination with mealtime Humalog (insulin lispro). The trial’s primary outcome is change in A1c from baseline to 24 weeks. The trial will also observe other key outcomes, such as the rate of hypoglycemic events (also known as time below zone), the dose of insulin required per body weight, and effects on the immune system. Participants will be randomly placed on either Mylan’s insulin glargine or Sanofi’s Lantus for the duration of 24 weeks.

The trial will enroll 500 participants with type 1 diabetes (a partner study in type 2 diabetes is simultaneously occurring – see below). To participate in the study, volunteers must be 18-65 years old, have a body mass index between 18 and 35, and an A1c below 9.5% at screening. Exclusion criteria include a history of two or more severe hypoglycemic events six months prior to screening, a history of drug or alcohol dependence during the year prior to screening, history of using animal insulin within the past three years, or any previous use of “biosimilar” insulin glargine, among others. As of now, there is only one location posted in Texas for the trial, though we expect more locations will be posted. For more information, please contact Julia Moore at +1 (724) 5141800 ext 1868 or at Julia.moore@mylan.com, or visit the ClinicalTrials.Gov website. -AJW

INSTRIDE 2 Non-Inferiority Study to Compare the Efficacy and Safety of Mylan’s Insulin Glargine with Lantus in People with Type 2 Diabetes

Clinical Identifier: NCT02227875

This partner study of the INSTRIDE 1 trial will test whether Mylan’s once-daily “biosimilar” insulin glargine is comparable to Sanofi’s Lantus in combination with other type 2 diabetes drugs. The trial’s primary outcome is change in A1c from baseline to 24 weeks. The trial will also observe other outcomes, including the rate of hypoglycemic events and effects on the immune system. Participants will be randomly placed on either Mylan’s insulin glargine or Sanofi’s Lantus for the duration of 24 weeks.

The trial is hoping to enroll 600 participants with type 2 diabetes. To participate, volunteers must be 18-65 years old, have been diagnosed with type 2 diabetes over a year prior to screening, have no previous history of insulin use OR have only used once-daily Lantus for at least three months prior to the study, have a BMI between 18 and 40, and an A1c under 10.5%. Exclusion criteria include a history of two or more severe hypoglycemic events six months prior to screening, a history of drug or alcohol dependence during the year prior to screening, history of using animal insulin within the past three years, or any previous use of “biosimilar” insulin glargine, among others. As of now, there is only one location posted in Texas for the trial, though we will keep updated when more locations are posted. For more information, please contact Julia Moore at +1 (724) 5141800 ext 1868 or at Julia.moore@mylan.com, or visit the ClinicalTrials.Gov website. -AJW

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