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

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ClinicalTrials.gov Identifier: NCT02227875
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : August 13, 2020
Last Update Posted : March 3, 2022
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )

Study Description
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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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Mylan's insulin glargine Drug: Lantus® Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multi-center, Parallel Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients
Study Start Date : August 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mylan's insulin Glargine
receive Mylan's insulin Glargine
 Drug: Mylan's insulin glargine
Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
Active Comparator: Lantus®
receive Lantus®
 Drug: Lantus®
For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c From Baseline to 24 Weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Rate of Hypoglycemic Events Per 30 Days [ Time Frame: Baseline and up to 24 weeks ]
    The change from baseline at 12 and 24 weeks is reported

  2. Hypoglycemia Occurrence [ Time Frame: 24 weeks ]
    Overall hypoglycemic incidence during treatment period

  3. Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [ Time Frame: Week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity

  4. Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time [ Time Frame: week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity

  5. Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [ Time Frame: week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity

  6. Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time [ Time Frame: Week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227875


Locations
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Sponsors and Collaborators
Mylan Inc.
Mylan GmbH
Investigators
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Principal Investigator: Thomas Blevins, MD Texas Diabetes & Endocrinology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02227875    
Other Study ID Numbers: MYL-GAI-3002
First Posted: August 28, 2014    Key Record Dates
Results First Posted: August 13, 2020
Last Update Posted: March 3, 2022
Last Verified: March 2022
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs