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)

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 1 Diabetes Mellitus Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

558

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

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Mylan Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E IM7
        • Mylan Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Mylan Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Mylan Investigational Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • Mylan Investigational Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Mylan Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • Mylan Investigational Site
      • Brno, Czechia, 656 91
        • Mylan Investigational Site
      • Broumov, Czechia, 55016
        • Mylan Investigational Site
      • Bruntal, Czechia, 792 01
        • Mylan Investigational Site
      • Ceske Budejovice, Czechia, 370 00
        • Mylan Investigational Site
      • Olomouc, Czechia, 77900
        • Mylan Investigational Site
      • Pardubice, Czechia, 530 02
        • Mylan Investigational Site
      • Praha 10, Czechia, 100 00
        • Mylan Investigational Site
      • Praha 10, Czechia, 100 34
        • Mylan Investigational Site
  • Estonia
      • Parnu, Estonia, 80018
        • Mylan Investigational Site
      • Tallinn, Estonia, 13419
        • Mylan Investigational Site
      • Tartu, Estonia, 51014
        • Mylan Investigational Site
  • Germany
      • Hamburg, Germany, 21073
        • Mylan Investigational Site
      • Hamburg, Germany, 22603
        • Mylan Investigational Site
    • Anhalt
      • Hohenmölsen, Anhalt, Germany, 06679
        • Mylan Investigational Site
    • Baden Wuerttemberg
      • Wangen im Allgau, Baden Wuerttemberg, Germany, 88239
        • Mylan Investigational Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • Mylan Investigational Site
      • Schweinfurt, Bayern, Germany, 97421
        • Mylan Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
        • Mylan Investigational Site
    • Nordrhein Westfalen
      • Muenster, Nordrhein Westfalen, Germany, 48145
        • Mylan Investigational Site
    • Saarland
      • Sankt Ingbert, Saarland, Germany, 66386
        • Mylan Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Mylan Investigational Site
  • Hungary
      • Baja, Hungary, 6500
        • Mylan Investigational Site
      • Budapest, Hungary, 1033
        • Mylan Investigational Site
      • Budapest, Hungary, 1083
        • Mylan Investigational Site
      • Budapest, Hungary, 1088
        • Mylan Investigational Site
      • Eger, Hungary, 3300
        • Mylan Investigational Site
      • Gyula, Hungary, 5700
        • Mylan Investigational Site
      • Letavertes, Hungary, 4281
        • Mylan Investigational Site
      • Mako, Hungary, H-6900
        • Mylan Investigational Site
      • Miskolc, Hungary, 3530
        • Mylan Investigational Site
      • Szeged, Hungary, 6722
        • Mylan Investigational Site
  • Latvia
      • Kuldiga, Latvia, LC-3301
        • Mylan Investigational Site
      • Limbazi, Latvia, 4001
        • Mylan Investigational Site
      • Ogre, Latvia, LV-5001
        • Mylan Investigational Site
      • Riga, Latvia, LV-1011
        • Mylan Investigational Site
      • Riga, Latvia, LV-1050
        • Mylan Investigational Site
      • Riga, Latvia, LV1002
        • Mylan Investigational Site
      • Sigulda, Latvia, LV-3200
        • Mylan Investigational Site
      • Talsi, Latvia, LV-3200
        • Mylan Investigational Site
  • Romania
      • Bacau, Romania, 600164
        • Mylan Investigational Site
      • Baia Mare, Romania, 430222
        • Mylan Investigational Site
      • Bucuresti, Romania, 010825
        • Mylan Investigational Site
      • Bucuresti, Romania, 061072
        • Mylan Investigational Site
      • Buzau, Romania, 120203
        • Mylan Investigational Site
      • Cluj Napoca, Romania, 400349
        • Mylan Investigational Site
      • Galati, Romania, 800578
        • Mylan Investigational Site
      • Iasi, Romania, 700503
        • Mylan Investigational Site
      • Oradea, Romania, 410169
        • Mylan Investigational Site
      • Oradea, Romania, 410469
        • Mylan Investigational Site
      • Timisoara, Romania, 300456
        • Mylan Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97517
        • Mylan Investigational Site
      • Bardejov, Slovakia, 08501
        • Mylan Investigational Site
      • Bratislava, Slovakia, 82106
        • Mylan Investigational Site
      • Bratislava, Slovakia, 83331
        • Mylan Investigational Site
      • Bratislava, Slovakia, 85101
        • Mylan Investigational Site
      • Dolny Kubin, Slovakia, 02601
        • Mylan Investigational Site
      • Kosice, Slovakia, 04011
        • Mylan Investigational Site
      • Levice, Slovakia, 93401
        • Mylan Investigational Site
      • Lubochna, Slovakia, 03491
        • Mylan Investigational Site
      • Nove Mesto nad Vahom, Slovakia, 91501
        • Mylan Investigational Site
      • Nove Zamky, Slovakia, 94002
        • Mylan Investigational Site
      • Presov, Slovakia, 08001
        • Mylan Investigational Site
      • Prievidza, Slovakia, 97101
        • Mylan Investigational Site
      • Pruske, Slovakia, 01852
        • Mylan Investigational Site
      • Rimavska Sobota, Slovakia, 97901
        • Mylan Investigational Site
      • Sabinov, Slovakia, 08301
        • Mylan Investigational Site
      • Skalica, Slovakia, 90901
        • Mylan Investigational Site
      • Sturovo, Slovakia, 943 01
        • Mylan Investigational Site
      • Trebisov, Slovakia, 07501
        • Mylan Investigational Site
      • Zilina, Slovakia, 01001
        • Mylan Investigational Site
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Mylan Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1501
        • Mylan Investigational Site
      • Johannesburg, Gauteng, South Africa, 1619
        • Mylan Investigational Site
      • Johannesburg, Gauteng, South Africa, 2198
        • Mylan Investigational Site
      • Krugersdorp, Gauteng, South Africa, 1739
        • Mylan Investigational Site
      • Pretoria, Gauteng, South Africa, 0002
        • Mylan Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Mylan Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Mylan Investigational Site
      • Cape Town, Western Cape, South Africa, 7580
        • Mylan Investigational Site
      • Cape Town, Western Cape, South Africa, 7708
        • Mylan Investigational Site
  • United Kingdom
      • Swansea, United Kingdom, SA6 6NL
        • Mylan Investigational Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Mylan Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Mylan Investigational Site
  • United States
    • California
      • Bell Gardens, California, United States, 90201
        • Mylan Investigational Site
      • Fresno, California, United States, 93720
        • Mylan Investigational Site
      • Greenbrae, California, United States, 93720
        • Mylan Investigational Site
      • La Jolla, California, United States, 92037
        • Mylan Investigational Site
      • La Mesa, California, United States, 91942
        • Mylan Investigational Site
      • Long Beach, California, United States, 90807
        • 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, 91950
        • Mylan Investigational Site
      • Northridge, California, United States, 91324
        • Mylan Investigational Site
      • Tustin, California, United States, 92780
        • Mylan Investigational Site
      • Walnut Creek, California, United States, 94598
        • 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
      • Hollywood, Florida, United States, 33021
        • 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
      • West Palm Beach, Florida, United States, 33401
        • Mylan Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Mylan Investigational Site
      • Columbus, Georgia, United States, 31904
        • Mylan Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Mylan Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Mylan Investigational Site
    • Illinois
      • Crystal Lake, Illinois, United States, 60012
        • Mylan Investigational Site
      • LaGrange, Illinois, United States, 60525
        • Mylan Investigational Site
      • Springfield, Illinois, United States, 62704
        • Mylan Investigational Site
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Mylan Investigational Site
      • Muncie, Indiana, United States, 47304
        • Mylan Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Mylan Investigational Site
      • Des Moines, Iowa, United States, 50314
        • Mylan Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Mylan Investigational Site
      • Topeka, Kansas, United States, 66606
        • Mylan Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Mylan Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Mylan Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Mylan Investigational Site
      • Omaha, Nebraska, United States, 68131
        • Mylan Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Mylan Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Mylan Investigational Site
      • Mineola, New York, United States, 11501
        • Mylan Investigational Site
      • Staten Island, New York, United States, 10301
        • Mylan Investigational Site
      • Syracuse, New York, United States, 13210
        • Mylan Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mylan Investigational Site
      • Burlington, North Carolina, United States, 27215
        • Mylan Investigational Site
      • Greensboro, North Carolina, United States, 27408
        • Mylan Investigational Site
      • Greenville, North Carolina, United States, 27834
        • 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
      • Mentor, Ohio, United States, 44060
        • Mylan Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Mylan Investigational Site
      • Corvallis, Oregon, United States, 97330
        • Mylan Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Mylan Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Mylan Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Mylan Investigational Site
      • Dallas, Texas, United States, 75231
        • Mylan Investigational Site
      • El Paso, Texas, United States, 79925
        • Mylan Investigational Site
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology
      • Round Rock, Texas, United States, 78681
        • Mylan Investigational Site
      • San Antonio, Texas, United States, 78258
        • 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
      • Renton, Washington, United States, 98057
        • Mylan Investigational Site
      • Tacoma, Washington, United States, 98405
        • Mylan Investigational Site
      • Vancouver, Washington, United States, 98664
        • 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 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.

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 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.

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

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 (Actual)

June 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

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-3001

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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