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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Mylan's insulin glargine; Drug: Lantus®

• Registration Number: NCT02227875
• Lead Sponsor: Mylan Inc.

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 to 24 weeks

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 established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-28
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Disposition First Submitted: 2017-03-03
• Disposition First Submitted QC: 2017-03-03
• Disposition First Posted: 2017-03-06
• Results First Submitted: 2020-02-24
• Results First Submitted QC: 2020-07-30
• Results First Posted: 2020-08-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mylan's insulin Glargine	Mylan's insulin glargine	receive Mylan's insulin Glargine
Lantus®	Lantus®	receive Lantus®

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to 24 Weeks	24 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of Hypoglycemic Events Per 30 Days	Baseline and up to 24 weeks	The change from baseline at 12 and 24 weeks is reported
Hypoglycemia Occurrence	24 weeks	Overall hypoglycemic incidence during treatment period
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time	Week 12 and week 24	Comparison of change from Baseline in Immunogenicity
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time	week 12 and week 24	Comparison of change from Baseline in Immunogenicity
Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time	week 12 and week 24	Comparison of change from Baseline in Immunogenicity
Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time	Week 12 and week 24	Comparison of change from Baseline in Immunogenicity

Trial Locations

Locations (1)

Mylan Investigational Site; 🇨🇳 Taipei, Taiwan