Type 2 DiabetesPhase 3INSTRIDE 2NCT02227875

Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

A Phase 3 study testing Mylan's insulin glargine and Lantus® in people with Type 2 Diabetes, run by Mylan Inc. at 120 sites in 6 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 (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 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: 560 participants
Where: 120 sitesin 6 countries
Study dates: Aug 2014to Dec 2015
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 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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

120 sites in 6 countries.

Country

City, postcode or hospital

120 sites in 6 countries

United States94 sites

Mylan Investigational Site
Albany, New York, 12206
Mylan Investigational Site
Anderson, Indiana, 46011
Mylan Investigational Site
Asheville, North Carolina, 28803
Mylan Investigational Site
Augusta, Kansas, 67010
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
Bristol, Tennessee, 34208
Mylan Investigational Site
Burlington, North Carolina, 27215
Mylan Investigational Site
Cary, North Carolina, 27513
Mylan Investigational Site
Chandler, Arizona, 85224
Mylan Investigational Site
Charleston, South Carolina, 29407
Mylan Investigational Site
Chesapeake, Virginia, 23321
Mylan Investigational Site
Chicago, Illinois, 60616
Mylan Investigational Site
Cincinnati, Ohio, 45236
Mylan Investigational Site
Cleveland, Ohio, 44122
Mylan Investigational Site
Columbus, Georgia, 31904
Mylan Investigational Site
Columbus, Ohio, 43201
Mylan Investigational Site
Cooper City, Florida, 33024
Mylan Investigational Site
Corpus Christi, Texas, 78404
Mylan Investigational Site
Council Bluffs, Iowa, 51501
Mylan Investigational Site
Crestview Hills, Kentucky, 41017
Mylan Investigational Site
Crystal Lake, Illinois, 60012
Mylan Investigational Site
Dallas, Texas, 75230
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
Gainesville, Georgia, 30501
Mylan Investigational Site
Greenbrae, California, 94904
Mylan Investigational Site
Greensboro, North Carolina, 27408
Mylan Investigational Site
Greenville, North Carolina, 28590
Mylan Investigational Site
Greer, South Carolina, 29651
Mylan Investigational Site
Hartsdale, New York, 10530
Mylan Investigational Site
Hialeah, Florida, 33012
Mylan Investigational Site
Hickory, North Carolina, 28601
Mylan Investigational Site
Honolulu, Hawaii, 96814
Mylan Investigational Site
Houston, Texas, 77004
Mylan Investigational Site
Houston, Texas, 77095
Mylan Investigational Site
Idaho Falls, Idaho, 83404
Mylan Investigational Site
Kansas City, Missouri, 64114
Mylan Investigational Site
Kingsport, Tennessee, 37660
Mylan Investigational Site
Las Vegas, Nevada, 89119
Mylan Investigational Site
Las Vegas, Nevada, 89128
Mylan Investigational Site
Lexington, Kentucky, 40503
Mylan Investigational Site
Lincoln, Nebraska, 68516
Mylan Investigational Site
Long Beach, California, 90807
Mylan Investigational Site
Los Angeles, California, 90057
Mylan Investigational Site
Los Gatos, California, 95032
Mylan Investigational Site
Manassas, Virginia, 20110
Mylan Investigational Site
McKinney, Texas, 75070
Mylan Investigational Site
Memphis, Tennessee, 38119
Mylan Investigational Site
Miami, Florida, 33142
Mylan Investigational Site
Miami, Florida, 33156
Mylan Investigational Site
Mission Hills, California, 91345
Mylan Investigational Site
Morehead City, North Carolina, 28557
Mylan Investigational Site
Nashua, New Hampshire, 03063
Mylan Investigational Site
National City, California, 47304
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
Orange, California, 92868
Mylan Investigational Site
Palm Harbor, Florida, 34684
Mylan Investigational Site
Palm Springs, California, 92262
Mylan Investigational Site
Pembroke Pines, Florida, 33028
Mylan Investigational Site
Port Charlotte, Florida, 33952
Mylan Investigational Site
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
Smithtown, New York, 11787
Mylan Investigational Site
South Jordan, Utah, 84095
Mylan Investigational Site
Spring, Texas, 77379
Mylan Investigational Site
Spring Valley, California, 91978
Mylan Investigational Site
Springfield, Illinois, 62704
Mylan Investigational Site
St Louis, Missouri, 63128
Mylan Investigational Site
Staten Island, New York, 10301
Mylan Investigational Site
Tacoma, Washington, 98405
Mylan Investigational Site
Topeka, Kansas, 66606
Mylan Investigational Site
Tustin, California, 92780
Mylan Investigational Site
Vancouver, Washington, 98405
Mylan Investigational Site
Victoria, Texas, 77901
Mylan Investigational Site
Walnut Creek, California, 94598
Mylan Investigational Site
Waltham, Massachusetts, 02453
Mylan Investigational Site
West Hills, California, 91307
Mylan Investigational Site
West Palm Beach, Florida, 33401
Mylan Investigational Site
Wichita, Kansas, 67207
Mylan Investigational Site
Wilmington, North Carolina, 28401
Mylan Investigational Site
Winter Haven, Florida, 33880

Other trials in United States

Slovakia13 sites

Mylan Investigational Site
Banská Bystrica
Mylan Investigational Site
Bardejov
Mylan Investigational Site
Bratislava
Mylan Investigational Site
Dolný Kubín
Mylan Investigational Site
Košice
Mylan Investigational Site
Levice
Mylan Investigational Site
Sabinov
Mylan Investigational Site
Šahy
Mylan Investigational Site
Stropkov
Mylan Investigational Site
Štúrovo
Mylan Investigational Site
Trebišov
Mylan Investigational Site
Trenčín
Mylan Investigational Site
Žilina

Other trials in Slovakia

South Africa6 sites

Mylan Investigational Site
Bloemfontein
Mylan Investigational Site
Cape Town, Western Cape, 7646
Mylan Investigational Site
Cape Town, Western Cape
Mylan Investigational Site
Durban, KwaZulu-Natal
Mylan Investigational Site
Johannesburg, Gauteng
Mylan Investigational Site
Worcester, Western Cape

Other trials in South Africa

South Korea3 sites

Mylan Investigational Site
Seoul, Gyeonggi-do
Mylan Investigational Site
Seoul, 110744
Mylan Investigational Site
Suwon, Gyeonggi-do

Other trials in South Korea

Jordan2 sites

Mylan Investigational Site
Amman
Mylan Investigational Site
Irbid

Other trials in Jordan

Taiwan2 sites

Mylan Investigational Site
Kaohsiung City
Mylan Investigational Site
Taipei

Other trials in Taiwan

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 2 Diabetes Mellitus Patients

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Mylan's insulin glargine, Lantus®
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

Mylan's insulin glargineDrug
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.
Lantus®Drug
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.

Study groups in NCT02227875
Study group	Role	What they receive
Mylan's insulin Glargine	Experimental	receive Mylan's insulin Glargine Receives: Drug: Mylan's insulin glargine
Lantus®	Active comparator	receive Lantus® 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 (6)

Rate of Hypoglycemic Events Per 30 Days
The change from baseline at 12 and 24 weeks is reported
Measured: Baseline and up to 24 weeks
Hypoglycemia Occurrence
Overall hypoglycemic incidence during treatment period
Measured: 24 weeks
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Comparison of change from Baseline in Immunogenicity
Measured: Week 12 and week 24
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Comparison of change from Baseline in Immunogenicity
Measured: week 12 and week 24
Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Comparison of change from Baseline in Immunogenicity
Measured: week 12 and week 24
Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Comparison of change from Baseline in Immunogenicity
Measured: Week 12 and week 24

Timeline

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

Aug 2014Dec 2015

First posted28 Aug 2014 (estimated)
Study startAug 2014
Primary completionDec 2015
Study completionDec 2015

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 2 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: 560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02227875
Sponsor's protocol ID: MYL-GAI-3002
Acronym: INSTRIDE 2
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?

See locations

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All Type 2 Diabetes trials

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 2 Diabetes Mellitus Patients
ClinicalTrials.gov ID: NCT02227875
Acronym / sponsor ID: INSTRIDE 2 / MYL-GAI-3002
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 560 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Collaborators: Mylan GmbH
Study start: Aug 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 28 Aug 2014 (estimated)
Results: Posted 13 Aug 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
Lantus®	Active comparator	Drug: Lantus®receive Lantus®

Who may qualify

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

Key inclusion criteria (8 listed)

Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:
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.

Key exclusion criteria (9 listed)

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.

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 glarginePatients 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.	Drug	Mylan's insulin Glargine
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.	Drug	Lantus®

Primary outcome

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

6 secondary outcomes

Rate of Hypoglycemic Events Per 30 Days
Time frame: Baseline and up to 24 weeks
Hypoglycemia Occurrence
Time frame: 24 weeks
Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Time frame: Week 12 and week 24
Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Time frame: 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
Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Time frame: Week 12 and week 24

Results and safety

Results posted to the registry on 13 Aug 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	277	240
Lantus®	283	250

Primary outcome: Change in HbA1c From Baseline to 24 Weeks

Time frame: 24 weeks. Least squares mean (95% Confidence Interval). Unit: percent

Measure	Mylan's Insulin Glargine n = 274	Lantus® n = 278
Value	-0.6 (-0.779 to -0.414)	-0.66 (-0.837 to -0.475)

Mylan's Insulin Glargine vs Lantus®: Mean Difference (Net): 0.06 (95% CI -0.098 to 0.218)

Population analysed: Intent-to-Treat Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mylan's Insulin Glargine	8 of 276 (2.9%)	177 of 276 (64.1%)	0 of 276
Lantus®	9 of 282 (3.2%)	164 of 282 (58.2%)	0 of 282

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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
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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

120 sites in 6 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 2 Diabetes, run by Mylan Inc. at 120 sites in 6 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 8 inclusion and 9 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 120 sites in United States, Slovakia, South Africa, South Korea, Jordan and 1 more country. 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 13 Aug 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 NCT02227875, 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.