Type 1 DiabetesPhase 3INSTRIDE 1NCT02227862

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

A Phase 3 study testing Mylan's insulin glargine and Lantus® in people with Type 1 Diabetes, run by Mylan Inc. at 162 sites in 11 countries.

Completed

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

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Mylan's insulin glargine and Lantus®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 558 participants
Where: 162 sitesin 11 countries
Study dates: Jun 2014to Jul 2016
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

162 sites in 11 countries.

Country

City, postcode or hospital

162 sites in 11 countries

United States72 sites

Mylan Investigational Site
Albany, New York, 12206
Mylan Investigational Site
Anderson, Indiana, 46011
Mylan Investigational Site
Asheville, North Carolina, 28803
Mylan Investigational Site
Atlanta, Georgia, 30318
Mylan Investigational Site
Austin, Texas, 78731
Mylan Investigational Site
Bell Gardens, California, 90201
Mylan Investigational Site
Bend, Oregon, 97701
Mylan Investigational Site
Billings, Montana, 59101
Mylan Investigational Site
Bradenton, Florida, 34208
Mylan Investigational Site
Burlington, North Carolina, 27215
Mylan Investigational Site
Chattanooga, Tennessee, 37411
Mylan Investigational Site
Chesapeake, Virginia, 23321
Mylan Investigational Site
Cincinnati, Ohio, 45236
Mylan Investigational Site
Columbus, Georgia, 31904
Mylan Investigational Site
Cooper City, Florida, 33024
Mylan Investigational Site
Corvallis, Oregon, 97330
Mylan Investigational Site
Council Bluffs, Iowa, 51501
Mylan Investigational Site
Crystal Lake, Illinois, 60012
Mylan Investigational Site
Dallas, Texas, 75231
Mylan Investigational Site
Des Moines, Iowa, 50314
Mylan Investigational Site
El Paso, Texas, 79925
Mylan Investigational Site
Fresno, California, 93720
Mylan Investigational Site
Greenbrae, California, 93720
Mylan Investigational Site
Greensboro, North Carolina, 27408
Mylan Investigational Site
Greenville, North Carolina, 27834
Mylan Investigational Site
Hialeah, Florida, 33012
Mylan Investigational Site
Hickory, North Carolina, 28601
Mylan Investigational Site
Hollywood, Florida, 33021
Mylan Investigational Site
Honolulu, Hawaii, 96814
Mylan Investigational Site
Idaho Falls, Idaho, 83404
Mylan Investigational Site
La Jolla, California, 92037
Mylan Investigational Site
La Mesa, California, 91942
Mylan Investigational Site
LaGrange, Illinois, 60525
Mylan Investigational Site
Las Vegas, Nevada, 89128
Mylan Investigational Site
Lexington, Kentucky, 40503
Mylan Investigational Site
Long Beach, California, 90807
Mylan Investigational Site
Los Gatos, California, 95032
Mylan Investigational Site
Manassas, Virginia, 20110
Mylan Investigational Site
Memphis, Tennessee, 38119
Mylan Investigational Site
Mentor, Ohio, 44060
Mylan Investigational Site
Miami, Florida, 33142
Mylan Investigational Site
Miami, Florida, 33156
Mylan Investigational Site
Mineola, New York, 11501
Mylan Investigational Site
Mission Hills, California, 91345
Mylan Investigational Site
Morehead City, North Carolina, 28557
Mylan Investigational Site
Muncie, Indiana, 47304
Mylan Investigational Site
National City, California, 91950
Mylan Investigational Site
New Port Richey, Florida, 34652
Mylan Investigational Site
Northridge, California, 91324
Mylan Investigational Site
Ogden, Utah, 84405
Mylan Investigational Site
Omaha, Nebraska, 68114
Mylan Investigational Site
Omaha, Nebraska, 68131
Mylan Investigational Site
Overland Park, Kansas, 66210
Mylan Investigational Site
Palm Harbor, Florida, 34684
Mylan Investigational Site
Renton, Washington, 98057
Mylan Investigational Site
Round Rock, Texas, 78681
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681
Mylan Investigational Site
Salt Lake City, Utah, 84102
Mylan Investigational Site
Salt Lake City, Utah, 84109
Mylan Investigational Site
Salt Lake City, Utah, 84121
Mylan Investigational Site
San Antonio, Texas, 78258
Mylan Investigational Site
South Jordan, Utah, 84095
Mylan Investigational Site
Springfield, Illinois, 62704
Mylan Investigational Site
Staten Island, New York, 10301
Mylan Investigational Site
Syracuse, New York, 13210
Mylan Investigational Site
Tacoma, Washington, 98405
Mylan Investigational Site
Topeka, Kansas, 66606
Mylan Investigational Site
Tustin, California, 92780
Mylan Investigational Site
Vancouver, Washington, 98664
Mylan Investigational Site
Walnut Creek, California, 94598
Mylan Investigational Site
West Palm Beach, Florida, 33401
Mylan Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

Slovakia20 sites

Mylan Investigational Site
Banská Bystrica, 97517
Mylan Investigational Site
Bardejov, 08501
Mylan Investigational Site
Bratislava, 82106
Mylan Investigational Site
Bratislava, 83331
Mylan Investigational Site
Bratislava, 85101
Mylan Investigational Site
Dolný Kubín, 02601
Mylan Investigational Site
Košice, 04011
Mylan Investigational Site
Levice, 93401
Mylan Investigational Site
Ľubochňa, 03491
Mylan Investigational Site
Nové Mesto nad Váhom, 91501
Mylan Investigational Site
Nové Zámky, 94002
Mylan Investigational Site
Prešov, 08001
Mylan Investigational Site
Prievidza, 97101
Mylan Investigational Site
Pruské, 01852
Mylan Investigational Site
Rimavská Sobota, 97901
Mylan Investigational Site
Sabinov, 08301
Mylan Investigational Site
Skalica, 90901
Mylan Investigational Site
Štúrovo, 943 01
Mylan Investigational Site
Trebišov, 07501
Mylan Investigational Site
Žilina, 01001

Other trials in Slovakia

Romania11 sites

Mylan Investigational Site
Bacau, 600164
Mylan Investigational Site
Baia Mare, 430222
Mylan Investigational Site
Bucharest, 010825
Mylan Investigational Site
Bucharest, 061072
Mylan Investigational Site
Buzău, 120203
Mylan Investigational Site
Cluj-Napoca, 400349
Mylan Investigational Site
Galati, 800578
Mylan Investigational Site
Iași, 700503
Mylan Investigational Site
Oradea, 410169
Mylan Investigational Site
Oradea, 410469
Mylan Investigational Site
Timișoara, 300456

Other trials in Romania

Germany10 sites

Mylan Investigational Site
Aschaffenburg, Bavaria, 63739
Mylan Investigational Site
Dresden, Saxony, 01307
Mylan Investigational Site
Frankfurt am Main, Hesse, 60596
Mylan Investigational Site
Hamburg, 21073
Mylan Investigational Site
Hamburg, 22603
Mylan Investigational Site
Hohenmölsen, Anhalt, 06679
Mylan Investigational Site
Münster, North Rhine-Westphalia, 48145
Mylan Investigational Site
Sankt Ingbert, Saarland, 66386
Mylan Investigational Site
Schweinfurt, Bavaria, 97421
Mylan Investigational Site
Wangen, Baden-Wurttemberg, 88239

Other trials in Germany

Hungary10 sites

Mylan Investigational Site
Baja, 6500
Mylan Investigational Site
Budapest, 1033
Mylan Investigational Site
Budapest, 1083
Mylan Investigational Site
Budapest, 1088
Mylan Investigational Site
Eger, 3300
Mylan Investigational Site
Gyula, 5700
Mylan Investigational Site
Létavértes, 4281
Mylan Investigational Site
Makó, H-6900
Mylan Investigational Site
Miskolc, 3530
Mylan Investigational Site
Szeged, 6722

Other trials in Hungary

South Africa10 sites

Mylan Investigational Site
Bloemfontein, Free State, 9301
Mylan Investigational Site
Cape Town, Western Cape, 7570
Mylan Investigational Site
Cape Town, Western Cape, 7580
Mylan Investigational Site
Cape Town, Western Cape, 7708
Mylan Investigational Site
Durban, KwaZulu-Natal, 4091
Mylan Investigational Site
Johannesburg, Gauteng, 1501
Mylan Investigational Site
Johannesburg, Gauteng, 1619
Mylan Investigational Site
Johannesburg, Gauteng, 2198
Mylan Investigational Site
Krugersdorp, Gauteng, 1739
Mylan Investigational Site
Pretoria, Gauteng, 0002

Other trials in South Africa

Czechia9 sites

Mylan Investigational Site
Brno, 625 00
Mylan Investigational Site
Brno, 656 91
Mylan Investigational Site
Broumov, 55016
Mylan Investigational Site
Bruntál, 792 01
Mylan Investigational Site
České Budějovice, 370 00
Mylan Investigational Site
Olomouc, 77900
Mylan Investigational Site
Pardubice, 530 02
Mylan Investigational Site
Prague, 100 00
Mylan Investigational Site
Prague, 100 34

Other trials in Czechia

Latvia8 sites

Mylan Investigational Site
Kuldīga, LC-3301
Mylan Investigational Site
Limbaži, 4001
Mylan Investigational Site
Ogre, LV-5001
Mylan Investigational Site
Riga, LV-1011
Mylan Investigational Site
Riga, LV-1050
Mylan Investigational Site
Riga, LV1002
Mylan Investigational Site
Sigulda, LV-3200
Mylan Investigational Site
Talsi, LV-3200

Other trials in Latvia

Canada6 sites

Mylan Investigational Site
Laval, Quebec, H7T 2P5
Mylan Investigational Site
Mirabel, Quebec, J7J 2K8
Mylan Investigational Site
Montreal, Quebec, H3A 1A1
Mylan Investigational Site
Red Deer, Alberta, T4N 6V7
Mylan Investigational Site
Vancouver, British Columbia, V6E IM7
Mylan Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Estonia3 sites

Mylan Investigational Site
Pärnu, 80018
Mylan Investigational Site
Tallinn, 13419
Mylan Investigational Site
Tartu, 51014

Other trials in Estonia

United Kingdom3 sites

Mylan Investigational Site
Leicester, Leicestershire, LE5 4PW
Mylan Investigational Site
Plymouth, Devon, PL6 8DH
Mylan Investigational Site
Swansea, SA6 6NL

Other trials in United Kingdom

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

Read the 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®.

Conditions: Type 1 Diabetes
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
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.
Lantus®Drug
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.

Study groups in NCT02227862
Study group	Role	What they receive
Mylan's Insulin Glargine	Experimental	Receive Mylan's Insulin Glargine plus insulin lispro. Receives: Drug: Mylan's insulin glargine
Lantus®	Active comparator	Receive Lantus® plus insulin lispro Receives: Drug: Lantus®

What is being measured

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

Change in HbA1c From Baseline to 24 Weeks
Measured: 24 weeks

Secondary outcomes (12)

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

Timeline

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

Jun 2014Jul 2016

First posted28 Aug 2014 (estimated)
Study startJun 2014
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 558 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02227862
Sponsor's protocol ID: MYL-GAI-3001
Acronym: INSTRIDE 1
Status last verified: Mar 2022
First submitted: 26 Aug 2014
Last updated: 3 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy AS, Ramaswamy S, Pathak D, Bowsher RR, Raiter Y, Aubonnet P, Barve A. Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies. BMC Endocr Disord. 2021 Jun 26;21(1):129. doi: 10.1186/s12902-021-00797-4.
PubMed 34174848

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02227862
Acronym / sponsor ID: INSTRIDE 1 / MYL-GAI-3001
Conditions: Type 1 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 558 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Collaborators: Mylan GmbH
Study start: Jun 2014 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 28 Aug 2014 (estimated)
Results: Posted 9 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mylan's Insulin Glargine	Experimental	Drug: Mylan's insulin glargineReceive Mylan's Insulin Glargine plus insulin lispro.
Lantus®	Active comparator	Drug: Lantus®Receive Lantus® plus insulin lispro

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mylan's insulin glargineAll 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.	Drug	Mylan's Insulin Glargine
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.	Drug	Lantus®

Primary outcome

Change in HbA1c From Baseline to 24 Weeks
Time frame: 24 weeks

12 secondary outcomes

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

Results and safety

Results posted to the registry on 9 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mylan's Insulin Glargine	280	261
Lantus®	278	256

Primary outcome: Change in HbA1c From Baseline to 24 Weeks

Time frame: 24 weeks. Least squares mean (Standard Error). Unit: percent

Measure	Mylan's Insulin Glargine n = 280	Lantus® n = 277
Value	0.14 (0.054)	0.11 (0.054)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 56 Weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mylan's Insulin Glargine	18 of 280 (6.4%)	225 of 225 (100%)	2 of 280
Lantus®	22 of 278 (7.9%)	239 of 239 (100%)	1 of 278

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34174848Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy AS, Ramaswamy S, Pathak D, Bowsher RR, Raiter Y, Aubonnet P, Barve A. Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies. BMC Endocr Disord. 2021 Jun 26;21(1):129. doi: 10.1186/s12902-021-00797-4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Blevins, MD principal investigator

Texas Diabetes & Endocrinology

162 sites in 11 countries: see every site and its status.

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, run by Mylan Inc. at 162 sites in 11 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 4 inclusion and 7 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 162 sites in United States, Slovakia, Romania, Germany, Hungary and 6 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 9 Mar 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 HbA1c From Baseline to 24 Weeks (time frame: 24 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 NCT02227862, which also lists 1 linked publication.

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.