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Type 1 Diabetes MellitusPhase 3NCT02666430

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

A Phase 3 study testing Mylan's insulin glargine and Lantus® in people with Type 1 Diabetes Mellitus, run by Mylan Inc. at 81 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 66 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Mylan's insulin glargine and Lantus®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
81 sitesin 8 countries
Study dates
Dec 2015to Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
  • 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.
  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
  • 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
  • Patients scheduled to receive another investigational drug during the extension study period
  • Any major elective surgery requiring hospitalization planned during the extension study period.
  • 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).

Trial locations and contacts

81 sites in 8 countries.

81 sites in 8 countries

United States39 sites

  • Mylan Investigator Site

    Albany, New York, 12206

  • Mylan Investigator Site

    Asheville, North Carolina, 28803

  • Mylan Investigator Site

    Atlanta, Georgia, 30318

  • Mylan Investigator Site

    Austin, Texas, 78731

  • Mylan Investigator Site

    Billings, Montana, 59101

  • Mylan Investigator Site

    Burlington, North Carolina, 27215

  • Mylan Investigator Site

    Chattanooga, Tennessee, 37411

  • Mylan Investigator Site

    Chesapeake, Virginia, 23321

  • Mylan Investigator Site

    Cincinnati, Ohio, 45236

  • Mylan Investigator Site

    Columbus, Georgia, 31904

  • Mylan Investigator Site

    Crystal Lake, Illinois, 60012

  • Mylan Investigator Site

    Dallas, Texas, 75231

  • Mylan Investigator Site

    Des Moines, Iowa, 50314

  • Mylan Investigator Site

    Fort Lauderdale, Florida, 33312

  • Mylan Investigator Site

    Fresno, California, 93720

  • Mylan Investigator Site

    Greenbrae, California, 94904

  • Mylan Investigator Site

    Greenville, North Carolina, 27834

  • Mylan Investigator Site

    Idaho Falls, Idaho, 83404

  • Mylan Investigator Site

    La Jolla, California, 92037

  • Mylan Investigator Site

    Lexington, Kentucky, 40503

  • Mylan Investigator Site

    Mentor, Ohio, 44060

  • Mylan Investigator Site

    Morehead City, North Carolina, 28557

  • Mylan Investigator Site

    New Port Richey, Florida, 34652

  • Mylan Investigator Site

    Northridge, California, 91324

  • Mylan Investigator Site

    Ogden, Utah, 84405

  • Mylan Investigator Site

    Omaha, Nebraska, 68131

  • Mylan Investigator Site

    Overland Park, Kansas, 66210

  • Mylan Investigator Site

    Palm Harbor, Florida, 34684

  • Mylan Investigator Site

    Renton, Washington, 98057

  • Mylan Investigator Site

    Salt Lake City, Utah, 84121

  • Mylan Investigator Site

    San Antonio, Texas, 78258

  • Mylan Investigator Site

    Springfield, Illinois, 62711

  • Mylan Investigator Site

    Staten Island, New York, 10301

  • Mylan Investigator Site

    Syracuse, New York, 13210

  • Mylan Investigator Site

    Tacoma, Washington, 98405

  • Mylan Investigator Site

    Tustin, California, 92780

  • Mylan Investigator Site

    Vancouver, Washington, 98664

  • Mylan Investigator Site

    West Palm Beach, Florida, 33401

  • Mylan Investigator Site

    Wilmington, North Carolina, 28401

Other trials in United States

Slovakia11 sites

  • Mylan Investigator Site

    Bratislava, 82107

  • Mylan Investigator Site

    Bratislava, 85101

  • Mylan Investigator Site

    Dolný Kubín, 02601

  • Mylan Investigator Site

    Levice, 93401

  • Mylan Investigator Site

    Ľubochňa, 03491

  • Mylan Investigator Site

    Nové Zámky, 940 02

  • Mylan Investigator Site

    Prievidza, 97101

  • Mylan Investigator Site

    Rimavská Sobota, 97901

  • Mylan Investigator Site

    Štúrovo, 94301

  • Mylan Investigator Site

    Trebišov, 07501

  • Mylan Investigator Site

    Žilina, 01001

Other trials in Slovakia

Czechia6 sites

  • Mylan Investigator Site

    Brno-Bohunice, 625 00

  • Mylan Investigator Site

    České Budějovice, 370 01

  • Mylan Investigator Site

    Olomouc, 77900

  • Mylan Investigator Site

    Pardubice, 530 02

  • Mylan Investigator Site

    Prague, 100 34

  • Mylan Investigator Site

    Prague, 120 00

Other trials in Czechia

Hungary6 sites

  • Mylan Investigator Site

    Budapest, 1033

  • Mylan Investigator Site

    Budapest, 1088

  • Mylan Investigator Site

    Eger, 3300

  • Mylan Investigator Site

    Létavértes, 4281

  • Mylan Investigator Site

    Miskolc, 3530

  • Mylan Investigator Site

    Szeged, H-6722

Other trials in Hungary

Latvia6 sites

  • Mylan Investigator Site

    Limbaži, LV-4001

  • Mylan Investigator Site

    Ogre, LV-5001

  • Mylan Investigator Site

    Riga, LV-1011

  • Mylan Investigator Site

    Riga, LV-1050

  • Mylan Investigator Site

    Sigulda, LV-2150

  • Mylan Investigator Site

    Talsi, LV-3200

Other trials in Latvia

Canada5 sites

  • Mylan Investigator Site

    Laval, Quebec

  • Mylan Investigator Site

    Montreal, Quebec

  • Mylan Investigator Site

    Red Deer, Alberta

  • Mylan Investigator Site.

    Vancouver, British Columbia

  • Mylan Investigator Site

    Winnipeg, Manitoba

Other trials in Canada

Germany5 sites

  • Mylan Investigator Site

    Aschaffenburg, Bavaria, 63739

  • Mylan Investigator Site

    Hamburg, 20173

  • Mylan Investigator Site

    Hamburg, 22607

  • Mylan Investigator Site

    Hohenmölsen, Saxony-Anhalt, 06679

  • Mylan Investigator Site

    Münster, North Rhine-Westphalia, 48145

Other trials in Germany

Estonia3 sites

  • Mylan Investigator Site

    Pärnu, 80018

  • Mylan Investigator Site

    Tallinn, 13419

  • Mylan Investigator Site

    Tartu, 51014

Other trials in Estonia

About this study

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: 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.

Read the 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.

Being tested
Mylan's insulin glargine, Lantus®
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mylan's insulin glargineDrug

  • Lantus®Drug

Study groups in NCT02666430
Study groupRoleWhat they receive
Mylan's insulin glargineExperimentalPatients 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.
Receives: Drug: Mylan's insulin glargine
Lantus®Active comparatorPatients 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.
Receives: Drug: Lantus®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c (HbA1c) From Baseline

    Measured: Baseline to 36 weeks

Secondary outcomes (10)

  1. Change From Baseline in Fasting Plasma Glucose

    Measured: Baseline to 36 weeks

  2. Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline

    Measured: Baseline to 36 weeks

  3. Change From Baseline Total Daily Insulin Dose

    Measured: Baseline to 36 weeks

  4. Local and Systemic Allergic Reactions

    Measured: Baseline to 40 weeks

  5. Hypoglycemic Rate

    Measured: Baseline to 36 weeks

  6. Hypoglycemic Incidence

    Measured: Baseline to 36 weeks

  7. Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay

    Measured: Baseline to 36 weeks

  8. Change From Baseline in Total Insulin Antibodies - Lantus Assay

    Measured: Baseline to 36 weeks

  9. Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay

    Measured: Baseline to 36 weeks

  10. Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay

    Measured: Baseline to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02666430
Sponsor's protocol ID
MYL-1501D-3003
Status last verified
Mar 2022
First submitted
25 Jan 2016
Last updated
3 Mar 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mylan's insulin glargine and Lantus® in people with Type 1 Diabetes Mellitus, run by Mylan Inc. at 81 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Slovakia, Czechia, Hungary, Latvia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (HbA1c) From Baseline (time frame: Baseline to 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02666430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.

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