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)

March 1, 2022 updated by: Mylan Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan
        • Mylan Investigational Site
      • Irbid, Jordan
        • Mylan Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110744
        • Mylan Investigational Site
    • Gyeonggi-do
      • Seoul, Gyeonggi-do, Korea, Republic of
        • Mylan Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of
        • Mylan Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Mylan Investigational Site
      • Bardejov, Slovakia
        • Mylan Investigational Site
      • Bratislava, Slovakia
        • Mylan Investigational Site
      • Dolny Kubin, Slovakia
        • Mylan Investigational Site
      • Kosice, Slovakia
        • Mylan Investigational Site
      • Levice, Slovakia
        • Mylan Investigational Site
      • Sabinov, Slovakia
        • Mylan Investigational Site
      • Sahy, Slovakia
        • Mylan Investigational Site
      • Stropkov, Slovakia
        • Mylan Investigational Site
      • Sturovo, Slovakia
        • Mylan Investigational Site
      • Trebisov, Slovakia
        • Mylan Investigational Site
      • Trencin, Slovakia
        • Mylan Investigational Site
      • Zilina, Slovakia
        • Mylan Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • Mylan Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Mylan Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
        • Mylan Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7646
        • Mylan Investigational Site
      • Cape Town, Western Cape, South Africa
        • Mylan Investigational Site
      • Worcester, Western Cape, South Africa
        • Mylan Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Mylan Investigational Site
      • Taipei, Taiwan
        • Mylan Investigational Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Mylan Investigational Site
    • California
      • Bell Gardens, California, United States, 90201
        • Mylan Investigational Site
      • Fresno, California, United States, 93720
        • Mylan Investigational Site
      • Greenbrae, California, United States, 94904
        • Mylan Investigational Site
      • Long Beach, California, United States, 90807
        • Mylan Investigational Site
      • Los Angeles, California, United States, 90057
        • Mylan Investigational Site
      • Los Gatos, California, United States, 95032
        • Mylan Investigational Site
      • Mission Hills, California, United States, 91345
        • Mylan Investigational Site
      • National City, California, United States, 47304
        • Mylan Investigational Site
      • Northridge, California, United States, 91324
        • Mylan Investigational Site
      • Orange, California, United States, 92868
        • Mylan Investigational Site
      • Palm Springs, California, United States, 92262
        • Mylan Investigational Site
      • Spring Valley, California, United States, 91978
        • Mylan Investigational Site
      • Tustin, California, United States, 92780
        • Mylan Investigational Site
      • Walnut Creek, California, United States, 94598
        • Mylan Investigational Site
      • West Hills, California, United States, 91307
        • Mylan Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Mylan Investigational Site
      • Cooper City, Florida, United States, 33024
        • Mylan Investigational Site
      • Hialeah, Florida, United States, 33012
        • Mylan Investigational Site
      • Miami, Florida, United States, 33142
        • Mylan Investigational Site
      • Miami, Florida, United States, 33156
        • Mylan Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Mylan Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Mylan Investigational Site
      • Pembroke Pines, Florida, United States, 33028
        • Mylan Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • Mylan Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Mylan Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Mylan Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Mylan Investigational Site
      • Gainesville, Georgia, United States, 30501
        • Mylan Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Mylan Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Mylan Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Mylan Investigational Site
      • Crystal Lake, Illinois, United States, 60012
        • Mylan Investigational Site
      • Springfield, Illinois, United States, 62704
        • Mylan Investigational Site
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Mylan Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Mylan Investigational Site
      • Des Moines, Iowa, United States, 50314
        • Mylan Investigational Site
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Mylan Investigational Site
      • Topeka, Kansas, United States, 66606
        • Mylan Investigational Site
      • Wichita, Kansas, United States, 67207
        • Mylan Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Mylan Investigational Site
      • Lexington, Kentucky, United States, 40503
        • Mylan Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Mylan Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Mylan Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Mylan Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Mylan Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Mylan Investigational Site
      • Omaha, Nebraska, United States, 68114
        • Mylan Investigational Site
      • Omaha, Nebraska, United States, 68131
        • Mylan Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Mylan Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Mylan Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Mylan Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Mylan Investigational Site
      • Hartsdale, New York, United States, 10530
        • Mylan Investigational Site
      • Smithtown, New York, United States, 11787
        • Mylan Investigational Site
      • Staten Island, New York, United States, 10301
        • Mylan Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mylan Investigational Site
      • Burlington, North Carolina, United States, 27215
        • Mylan Investigational Site
      • Cary, North Carolina, United States, 27513
        • Mylan Investigational Site
      • Greensboro, North Carolina, United States, 27408
        • Mylan Investigational Site
      • Greenville, North Carolina, United States, 28590
        • Mylan Investigational Site
      • Hickory, North Carolina, United States, 28601
        • Mylan Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Mylan Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Mylan Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Mylan Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Mylan Investigational Site
      • Columbus, Ohio, United States, 43201
        • Mylan Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Mylan Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Mylan Investigational Site
      • Greer, South Carolina, United States, 29651
        • Mylan Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 34208
        • Mylan Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Mylan Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Mylan Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Mylan Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • Mylan Investigational Site
      • Dallas, Texas, United States, 75230
        • Mylan Investigational Site
      • Dallas, Texas, United States, 75231
        • Mylan Investigational Site
      • El Paso, Texas, United States, 79925
        • Mylan Investigational Site
      • Houston, Texas, United States, 77004
        • Mylan Investigational Site
      • Houston, Texas, United States, 77095
        • Mylan Investigational Site
      • McKinney, Texas, United States, 75070
        • Mylan Investigational Site
      • Round Rock, Texas, United States, 78681
        • Mylan Investigational Site
      • San Antonio, Texas, United States, 78258
        • Mylan Investigational Site
      • Spring, Texas, United States, 77379
        • Mylan Investigational Site
      • Victoria, Texas, United States, 77901
        • Mylan Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Mylan Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Mylan Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • Mylan Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Mylan Investigational Site
      • South Jordan, Utah, United States, 84095
        • Mylan Investigational Site
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Mylan Investigational Site
      • Manassas, Virginia, United States, 20110
        • Mylan Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Mylan Investigational Site
      • Vancouver, Washington, United States, 98405
        • Mylan Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c From Baseline to 24 Weeks
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and up to 24 weeks
Hypoglycemia Occurrence
Time Frame: 24 weeks
Overall hypoglycemic incidence during treatment period
24 weeks
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
Week 12 and week 24
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
week 12 and week 24
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
week 12 and week 24
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
Week 12 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Mylan GmbH

Investigators

  • Principal Investigator: Thomas Blevins, MD, Texas Diabetes & Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYL-GAI-3002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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