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Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1) (INSTRIDE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227862
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : March 9, 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 (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Mylan's insulin glargine Drug: Lantus® Phase 3

Detailed Description:
This trial is a multicenter, open-label, randomized, parallel-group trial in patients with Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 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 1 Diabetes Mellitus Patients
Actual Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mylan's Insulin Glargine
Receive Mylan's Insulin Glargine plus insulin lispro.
 Drug: Mylan's insulin glargine
All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
Active Comparator: Lantus®
Receive Lantus® plus insulin lispro
 Drug: Lantus®
All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.


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. Summary of Actual and Change From Baseline in HbA1c [ Time Frame: 24 and 52 weeks ]
  2. Change From Baseline in FPG Over Time [ Time Frame: 24 and 52 weeks ]
  3. Change From Baseline in 8-point SMBG Profile Over Time [ Time Frame: 24 and 52 weeks ]
  4. Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time [ Time Frame: 24 and 52 weeks ]
  5. Rate of Hypoglycemic Events Per 30 Days Over Time [ Time Frame: 24 and 52 weeks ]
  6. Hypoglycemia Occurrence [ Time Frame: 52 weeks ]
  7. Occurrence of Local and Systematic Reactions [ Time Frame: 52 weeks ]
  8. Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [ Time Frame: 24 and 52 weeks ]
  9. Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time [ Time Frame: 24 and 52 weeks ]
  10. Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [ Time Frame: 24 and 52 weeks ]
  11. Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time [ Time Frame: 24 and 52 weeks ]
  12. Proportion of Patients With HbA1c < 7% [ Time Frame: 24 and 52 weeks ]

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 T1DM per ADA 2014 criteria
  • Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
  • Glycosylated hemoglobin (HbA1c) ≤9.5% at screening.
  • Hemoglobin ≥9.0 g/dL at screening.

Exclusion Criteria:

  • History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
  • History of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior.
  • History of use of a regular immunomodulator 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 episodes of diabetic ketoacidosis 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.
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): NCT02227862


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: NCT02227862    
Other Study ID Numbers: MYL-GAI-3001
First Posted: August 28, 2014    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: March 3, 2022
Last Verified: March 2022
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs