Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

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: An Extension Study

The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multi-center, open-label, randomized clinical extension study in patients with T1DM will assess safety and efficacy of Mylan's insulin glargine and Lantus®.

Patients with an established diagnosis of T1DM per American Diabetes Association 2014 criteria who were randomized to the Lantus® treatment arm of the Mylan Glargine 3001 study, and who have completed the 52-week treatment period on Lantus® will be eligible to be screened for the MYL-1501D-3003 study.

Study Type

Interventional

Enrollment (Actual)

127

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
        • Mylan Investigator Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Mylan Investigator Site.
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Mylan Investigator Site
    • Quebec
      • Laval, Quebec, Canada
        • Mylan Investigator Site
      • Montreal, Quebec, Canada
        • Mylan Investigator Site
  • Czechia
      • Brno Bohunice, Czechia, 625 00
        • Mylan Investigator Site
      • Ceske Budejovice, Czechia, 370 01
        • Mylan Investigator Site
      • Olomouc, Czechia, 77900
        • Mylan Investigator Site
      • Pardubice, Czechia, 530 02
        • Mylan Investigator Site
      • Praha, Czechia, 120 00
        • Mylan Investigator Site
      • Praha 10, Czechia, 100 34
        • Mylan Investigator Site
  • Estonia
      • Parnu, Estonia, 80018
        • Mylan Investigator Site
      • Tallinn, Estonia, 13419
        • Mylan Investigator Site
      • Tartu, Estonia, 51014
        • Mylan Investigator Site
  • Germany
      • Hamburg, Germany, 20173
        • Mylan Investigator Site
      • Hamburg, Germany, 22607
        • Mylan Investigator Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • Mylan Investigator Site
    • Nordrhein Westfalen
      • Munster, Nordrhein Westfalen, Germany, 48145
        • Mylan Investigator Site
    • Sachsen Anhalt
      • Hohenmolsen, Sachsen Anhalt, Germany, 06679
        • Mylan Investigator Site
  • Hungary
      • Budapest, Hungary, 1033
        • Mylan Investigator Site
      • Budapest, Hungary, 1088
        • Mylan Investigator Site
      • Eger, Hungary, 3300
        • Mylan Investigator Site
      • Letavertes, Hungary, 4281
        • Mylan Investigator Site
      • Miskolc, Hungary, 3530
        • Mylan Investigator Site
      • Szeged, Hungary, H-6722
        • Mylan Investigator Site
  • Latvia
      • Limbazi, Latvia, LV-4001
        • Mylan Investigator Site
      • Ogre, Latvia, LV-5001
        • Mylan Investigator Site
      • Riga, Latvia, LV-1011
        • Mylan Investigator Site
      • Riga, Latvia, LV-1050
        • Mylan Investigator Site
      • Sigulda, Latvia, LV-2150
        • Mylan Investigator Site
      • Talsi, Latvia, LV-3200
        • Mylan Investigator Site
  • Slovakia
      • Bratislava, Slovakia, 82107
        • Mylan Investigator Site
      • Bratislava, Slovakia, 85101
        • Mylan Investigator Site
      • Dolny Kubin, Slovakia, 02601
        • Mylan Investigator Site
      • Levice, Slovakia, 93401
        • Mylan Investigator Site
      • Lubochna, Slovakia, 03491
        • Mylan Investigator Site
      • Nove Zamky, Slovakia, 940 02
        • Mylan Investigator Site
      • Prievidza, Slovakia, 97101
        • Mylan Investigator Site
      • Rimavska Sobota, Slovakia, 97901
        • Mylan Investigator Site
      • Sturovo, Slovakia, 94301
        • Mylan Investigator Site
      • Trebisov, Slovakia, 07501
        • Mylan Investigator Site
      • Zilina, Slovakia, 01001
        • Mylan Investigator Site
  • United States
    • California
      • Fresno, California, United States, 93720
        • Mylan Investigator Site
      • Greenbrae, California, United States, 94904
        • Mylan Investigator Site
      • La Jolla, California, United States, 92037
        • Mylan Investigator Site
      • Northridge, California, United States, 91324
        • Mylan Investigator Site
      • Tustin, California, United States, 92780
        • Mylan Investigator Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Mylan Investigator Site
      • New Port Richey, Florida, United States, 34652
        • Mylan Investigator Site
      • Palm Harbor, Florida, United States, 34684
        • Mylan Investigator Site
      • West Palm Beach, Florida, United States, 33401
        • Mylan Investigator Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Mylan Investigator Site
      • Columbus, Georgia, United States, 31904
        • Mylan Investigator Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Mylan Investigator Site
    • Illinois
      • Crystal Lake, Illinois, United States, 60012
        • Mylan Investigator Site
      • Springfield, Illinois, United States, 62711
        • Mylan Investigator Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mylan Investigator Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Mylan Investigator Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Mylan Investigator Site
    • Montana
      • Billings, Montana, United States, 59101
        • Mylan Investigator Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Mylan Investigator Site
    • New York
      • Albany, New York, United States, 12206
        • Mylan Investigator Site
      • Staten Island, New York, United States, 10301
        • Mylan Investigator Site
      • Syracuse, New York, United States, 13210
        • Mylan Investigator Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mylan Investigator Site
      • Burlington, North Carolina, United States, 27215
        • Mylan Investigator Site
      • Greenville, North Carolina, United States, 27834
        • Mylan Investigator Site
      • Morehead City, North Carolina, United States, 28557
        • Mylan Investigator Site
      • Wilmington, North Carolina, United States, 28401
        • Mylan Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Mylan Investigator Site
      • Mentor, Ohio, United States, 44060
        • Mylan Investigator Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Mylan Investigator Site
    • Texas
      • Austin, Texas, United States, 78731
        • Mylan Investigator Site
      • Dallas, Texas, United States, 75231
        • Mylan Investigator Site
      • San Antonio, Texas, United States, 78258
        • Mylan Investigator Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Mylan Investigator Site
      • Salt Lake City, Utah, United States, 84121
        • Mylan Investigator Site
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Mylan Investigator Site
    • Washington
      • Renton, Washington, United States, 98057
        • Mylan Investigator Site
      • Tacoma, Washington, United States, 98405
        • Mylan Investigator Site
      • Vancouver, Washington, United States, 98664
        • Mylan Investigator 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 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study.
  2. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
  3. The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point self-monitoring blood glucose, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the extension study.

  4. Female patients complying with the following:

    • Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of randomization throughout the entire study.
    • Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study.
    • Female patients who report surgical sterilization must have had the procedure at least 6 months prior to inclusion to MYL-GAI-3001 study.
    • All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES.
    • If female patients have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to inclusion in MYL-GAI-3001 study.

Exclusion Criteria:

  1. History or presence of a medical condition or disease that in the Investigator's opinion would place the patient at an unacceptable risk from trial participation.
  2. History of clinically significant (i.e., significant enough to alter the insulin dose requirement, as per the Investigator) acute bacterial, viral or fungal systemic infections in the 4 weeks prior to inclusion / randomization (recorded while collecting patient history) in to the MYL-1501D-3003 extension study
  3. Patients scheduled to receive another investigational drug during the extension study period
  4. Any major elective surgery requiring hospitalization planned during the extension study period.
  5. Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of ≥1.5 U/kg/day (Lantus® in U/kg/day or Mylan's insulin glargine in IU/kg/day).

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
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Drug: Mylan's insulin glargine
Active Comparator: Lantus®
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Drug: Lantus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hemoglobin A1c (HbA1c) From Baseline
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Fasting Plasma Glucose
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Change From Baseline Total Daily Insulin Dose
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Local and Systemic Allergic Reactions
Time Frame: Baseline to 40 weeks
Baseline to 40 weeks
Hypoglycemic Rate
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Hypoglycemic Incidence
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Change From Baseline in Total Insulin Antibodies - Lantus Assay
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay
Time Frame: Baseline to 36 weeks
Baseline to 36 weeks
Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay
Time Frame: Baseline to 36 weeks
Baseline to 36 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, Texas Diabetes & Endocrinology

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)

December 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

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-1501D-3003

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.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on Mylan's insulin glargine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe