MedDataX Logo

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

NCT ID: NCT02227862

Last Updated: 2022-03-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02227875

Type 2 Diabetes
COMPLETED PHASE3

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

NCT02666430

Type 1 Diabetes Mellitus
COMPLETED PHASE3

Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

NCT00046462

Diabetes Mellitus
COMPLETED PHASE3

Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

NCT00467376

Diabetes Mellitus
COMPLETED PHASE3

Mylan Insulin Glargine Study

NCT03376789

Diabetes Mellitus, Type 1
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mylan's Insulin Glargine

Receive Mylan's Insulin Glargine plus insulin lispro.

Group Type EXPERIMENTAL

Mylan's insulin glargine

Intervention Type 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 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®

Receive Lantus® plus insulin lispro

Group Type ACTIVE_COMPARATOR

Lantus®

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mylan GmbH

INDUSTRY

Sponsor Role collaborator

Mylan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Blevins, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Diabetes & Endocrinology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mylan Investigational Site

Bell Gardens, California, United States

Site Status

Mylan Investigational Site

Fresno, California, United States

Site Status

Mylan Investigational Site

Greenbrae, California, United States

Site Status

Mylan Investigational Site

La Jolla, California, United States

Site Status

Mylan Investigational Site

La Mesa, California, United States

Site Status

Mylan Investigational Site

Long Beach, California, United States

Site Status

Mylan Investigational Site

Los Gatos, California, United States

Site Status

Mylan Investigational Site

Mission Hills, California, United States

Site Status

Mylan Investigational Site

National City, California, United States

Site Status

Mylan Investigational Site

Northridge, California, United States

Site Status

Mylan Investigational Site

Tustin, California, United States

Site Status

Mylan Investigational Site

Walnut Creek, California, United States

Site Status

Mylan Investigational Site

Bradenton, Florida, United States

Site Status

Mylan Investigational Site

Cooper City, Florida, United States

Site Status

Mylan Investigational Site

Hialeah, Florida, United States

Site Status

Mylan Investigational Site

Hollywood, Florida, United States

Site Status

Mylan Investigational Site

Miami, Florida, United States

Site Status

Mylan Investigational Site

Miami, Florida, United States

Site Status

Mylan Investigational Site

New Port Richey, Florida, United States

Site Status

Mylan Investigational Site

Palm Harbor, Florida, United States

Site Status

Mylan Investigational Site

West Palm Beach, Florida, United States

Site Status

Mylan Investigational Site

Atlanta, Georgia, United States

Site Status

Mylan Investigational Site

Columbus, Georgia, United States

Site Status

Mylan Investigational Site

Honolulu, Hawaii, United States

Site Status

Mylan Investigational Site

Idaho Falls, Idaho, United States

Site Status

Mylan Investigational Site

Crystal Lake, Illinois, United States

Site Status

Mylan Investigational Site

LaGrange, Illinois, United States

Site Status

Mylan Investigational Site

Springfield, Illinois, United States

Site Status

Mylan Investigational Site

Anderson, Indiana, United States

Site Status

Mylan Investigational Site

Muncie, Indiana, United States

Site Status

Mylan Investigational Site

Council Bluffs, Iowa, United States

Site Status

Mylan Investigational Site

Des Moines, Iowa, United States

Site Status

Mylan Investigational Site

Overland Park, Kansas, United States

Site Status

Mylan Investigational Site

Topeka, Kansas, United States

Site Status

Mylan Investigational Site

Lexington, Kentucky, United States

Site Status

Mylan Investigational Site

Billings, Montana, United States

Site Status

Mylan Investigational Site

Omaha, Nebraska, United States

Site Status

Mylan Investigational Site

Omaha, Nebraska, United States

Site Status

Mylan Investigational Site

Las Vegas, Nevada, United States

Site Status

Mylan Investigational Site

Albany, New York, United States

Site Status

Mylan Investigational Site

Mineola, New York, United States

Site Status

Mylan Investigational Site

Staten Island, New York, United States

Site Status

Mylan Investigational Site

Syracuse, New York, United States

Site Status

Mylan Investigational Site

Asheville, North Carolina, United States

Site Status

Mylan Investigational Site

Burlington, North Carolina, United States

Site Status

Mylan Investigational Site

Greensboro, North Carolina, United States

Site Status

Mylan Investigational Site

Greenville, North Carolina, United States

Site Status

Mylan Investigational Site

Hickory, North Carolina, United States

Site Status

Mylan Investigational Site

Morehead City, North Carolina, United States

Site Status

Mylan Investigational Site

Wilmington, North Carolina, United States

Site Status

Mylan Investigational Site

Cincinnati, Ohio, United States

Site Status

Mylan Investigational Site

Mentor, Ohio, United States

Site Status

Mylan Investigational Site

Bend, Oregon, United States

Site Status

Mylan Investigational Site

Corvallis, Oregon, United States

Site Status

Mylan Investigational Site

Chattanooga, Tennessee, United States

Site Status

Mylan Investigational Site

Memphis, Tennessee, United States

Site Status

Mylan Investigational Site

Austin, Texas, United States

Site Status

Mylan Investigational Site

Dallas, Texas, United States

Site Status

Mylan Investigational Site

El Paso, Texas, United States

Site Status

Mylan Investigational Site

Round Rock, Texas, United States

Site Status

Texas Diabetes & Endocrinology

Round Rock, Texas, United States

Site Status

Mylan Investigational Site

San Antonio, Texas, United States

Site Status

Mylan Investigational Site

Ogden, Utah, United States

Site Status

Mylan Investigational Site

Salt Lake City, Utah, United States

Site Status

Mylan Investigational Site

Salt Lake City, Utah, United States

Site Status

Mylan Investigational Site

Salt Lake City, Utah, United States

Site Status

Mylan Investigational Site

South Jordan, Utah, United States

Site Status

Mylan Investigational Site

Chesapeake, Virginia, United States

Site Status

Mylan Investigational Site

Manassas, Virginia, United States

Site Status

Mylan Investigational Site

Renton, Washington, United States

Site Status

Mylan Investigational Site

Tacoma, Washington, United States

Site Status

Mylan Investigational Site

Vancouver, Washington, United States

Site Status

Mylan Investigational Site

Red Deer, Alberta, Canada

Site Status

Mylan Investigational Site

Vancouver, British Columbia, Canada

Site Status

Mylan Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Mylan Investigational Site

Laval, Quebec, Canada

Site Status

Mylan Investigational Site

Mirabel, Quebec, Canada

Site Status

Mylan Investigational Site

Montreal, Quebec, Canada

Site Status

Mylan Investigational Site

Brno, , Czechia

Site Status

Mylan Investigational Site

Brno, , Czechia

Site Status

Mylan Investigational Site

Broumov, , Czechia

Site Status

Mylan Investigational Site

Bruntál, , Czechia

Site Status

Mylan Investigational Site

České Budějovice, , Czechia

Site Status

Mylan Investigational Site

Olomouc, , Czechia

Site Status

Mylan Investigational Site

Pardubice, , Czechia

Site Status

Mylan Investigational Site

Prague, , Czechia

Site Status

Mylan Investigational Site

Prague, , Czechia

Site Status

Mylan Investigational Site

Pärnu, , Estonia

Site Status

Mylan Investigational Site

Tallinn, , Estonia

Site Status

Mylan Investigational Site

Tartu, , Estonia

Site Status

Mylan Investigational Site

Hohenmölsen, Anhalt, Germany

Site Status

Mylan Investigational Site

Wangen, Baden-Wurttemberg, Germany

Site Status

Mylan Investigational Site

Aschaffenburg, Bavaria, Germany

Site Status

Mylan Investigational Site

Schweinfurt, Bavaria, Germany

Site Status

Mylan Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

Mylan Investigational Site

Münster, North Rhine-Westphalia, Germany

Site Status

Mylan Investigational Site

Sankt Ingbert, Saarland, Germany

Site Status

Mylan Investigational Site

Dresden, Saxony, Germany

Site Status

Mylan Investigational Site

Hamburg, , Germany

Site Status

Mylan Investigational Site

Hamburg, , Germany

Site Status

Mylan Investigational Site

Baja, , Hungary

Site Status

Mylan Investigational Site

Budapest, , Hungary

Site Status

Mylan Investigational Site

Budapest, , Hungary

Site Status

Mylan Investigational Site

Budapest, , Hungary

Site Status

Mylan Investigational Site

Eger, , Hungary

Site Status

Mylan Investigational Site

Gyula, , Hungary

Site Status

Mylan Investigational Site

Létavértes, , Hungary

Site Status

Mylan Investigational Site

Makó, , Hungary

Site Status

Mylan Investigational Site

Miskolc, , Hungary

Site Status

Mylan Investigational Site

Szeged, , Hungary

Site Status

Mylan Investigational Site

Kuldīga, , Latvia

Site Status

Mylan Investigational Site

Limbaži, , Latvia

Site Status

Mylan Investigational Site

Ogre, , Latvia

Site Status

Mylan Investigational Site

Riga, , Latvia

Site Status

Mylan Investigational Site

Riga, , Latvia

Site Status

Mylan Investigational Site

Riga, , Latvia

Site Status

Mylan Investigational Site

Sigulda, , Latvia

Site Status

Mylan Investigational Site

Talsi, , Latvia

Site Status

Mylan Investigational Site

Bacau, , Romania

Site Status

Mylan Investigational Site

Baia Mare, , Romania

Site Status

Mylan Investigational Site

Bucharest, , Romania

Site Status

Mylan Investigational Site

Bucharest, , Romania

Site Status

Mylan Investigational Site

Buzău, , Romania

Site Status

Mylan Investigational Site

Cluj-Napoca, , Romania

Site Status

Mylan Investigational Site

Galati, , Romania

Site Status

Mylan Investigational Site

Iași, , Romania

Site Status

Mylan Investigational Site

Oradea, , Romania

Site Status

Mylan Investigational Site

Oradea, , Romania

Site Status

Mylan Investigational Site

Timișoara, , Romania

Site Status

Mylan Investigational Site

Banská Bystrica, , Slovakia

Site Status

Mylan Investigational Site

Bardejov, , Slovakia

Site Status

Mylan Investigational Site

Bratislava, , Slovakia

Site Status

Mylan Investigational Site

Bratislava, , Slovakia

Site Status

Mylan Investigational Site

Bratislava, , Slovakia

Site Status

Mylan Investigational Site

Dolný Kubín, , Slovakia

Site Status

Mylan Investigational Site

Košice, , Slovakia

Site Status

Mylan Investigational Site

Levice, , Slovakia

Site Status

Mylan Investigational Site

Ľubochňa, , Slovakia

Site Status

Mylan Investigational Site

Nové Mesto nad Váhom, , Slovakia

Site Status

Mylan Investigational Site

Nové Zámky, , Slovakia

Site Status

Mylan Investigational Site

Prešov, , Slovakia

Site Status

Mylan Investigational Site

Prievidza, , Slovakia

Site Status

Mylan Investigational Site

Pruské, , Slovakia

Site Status

Mylan Investigational Site

Rimavská Sobota, , Slovakia

Site Status

Mylan Investigational Site

Sabinov, , Slovakia

Site Status

Mylan Investigational Site

Skalica, , Slovakia

Site Status

Mylan Investigational Site

Štúrovo, , Slovakia

Site Status

Mylan Investigational Site

Trebišov, , Slovakia

Site Status

Mylan Investigational Site

Žilina, , Slovakia

Site Status

Mylan Investigational Site

Bloemfontein, Free State, South Africa

Site Status

Mylan Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Mylan Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Mylan Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Mylan Investigational Site

Krugersdorp, Gauteng, South Africa

Site Status

Mylan Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Mylan Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Mylan Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Mylan Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Mylan Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Mylan Investigational Site

Plymouth, Devon, United Kingdom

Site Status

Mylan Investigational Site

Leicester, Leicestershire, United Kingdom

Site Status

Mylan Investigational Site

Swansea, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Czechia Estonia Germany Hungary Latvia Romania Slovakia South Africa United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34174848 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MYL-GAI-3001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients
NCT04022993 COMPLETED PHASE3
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
NCT01683266 COMPLETED PHASE3
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
NCT01600950 COMPLETED PHASE1
A Study in Adults With Type 1 Diabetes
NCT01421147 COMPLETED PHASE3
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
NCT01195454 COMPLETED PHASE1
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
NCT01569841 COMPLETED PHASE3
Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
NCT00949442 COMPLETED PHASE4
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
NCT01658579 COMPLETED PHASE2
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
NCT01676220 COMPLETED PHASE3
Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes
NCT00276393 COMPLETED PHASE4
Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
NCT03371082 COMPLETED PHASE3
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
NCT01499095 COMPLETED PHASE3
Glulisine + Lantus in Type I Patients
NCT00545337 COMPLETED PHASE3
Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
NCT01868529 COMPLETED PHASE1
PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes
NCT02506647 COMPLETED PHASE1
Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus
NCT02201199 COMPLETED PHASE1
Insulin Glargine in Type 1 Diabetes Mellitus
NCT00272090 COMPLETED PHASE3
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
NCT00694122 COMPLETED PHASE3
A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)
NCT02059161 COMPLETED PHASE3
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
NCT01357603 COMPLETED PHASE1
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
NCT01499082 COMPLETED PHASE3
Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
NCT00046501 COMPLETED PHASE3
Glulisine + Lantus in Type I Patients
NCT00546702 COMPLETED PHASE3
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
NCT00349986 TERMINATED PHASE4
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)
NCT02059174 COMPLETED PHASE1