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

NCT02227862 | Completed Phase 3 Results

• 1 other identifier: MYL-GAI-3001
• Study Type: interventional
• Target: 558
• Locations: 11 countries
• Sites: 162

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to 24 Weeks

  24 weeks

Secondary Outcomes (12)

• Summary of Actual and Change From Baseline in HbA1c

  24 and 52 weeks

• Change From Baseline in FPG Over Time

  24 and 52 weeks

• Change From Baseline in 8-point SMBG Profile Over Time

  24 and 52 weeks

• Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time

  24 and 52 weeks

• Rate of Hypoglycemic Events Per 30 Days Over Time

  24 and 52 weeks

Study Arms (2)

Mylan's Insulin Glargine

EXPERIMENTAL

Receive Mylan's Insulin Glargine plus insulin lispro.

Drug: Mylan's insulin glargine

Lantus®

ACTIVE COMPARATOR

Receive Lantus® plus insulin lispro

Drug: Lantus®

Interventions

Mylan's insulin glargine 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.

Mylan's Insulin Glargine

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.

Lantus®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (162)

Mylan Investigational Site

Bell Gardens, California, 90201, United States

Location

Mylan Investigational Site

Fresno, California, 93720, United States

Location

Mylan Investigational Site

Greenbrae, California, 93720, United States

Location

Mylan Investigational Site

La Jolla, California, 92037, United States

Location

Mylan Investigational Site

La Mesa, California, 91942, United States

Location

Mylan Investigational Site

Long Beach, California, 90807, United States

Location

Mylan Investigational Site

Los Gatos, California, 95032, United States

Location

Mylan Investigational Site

Mission Hills, California, 91345, United States

Location

Mylan Investigational Site

National City, California, 91950, United States

Location

Mylan Investigational Site

Northridge, California, 91324, United States

Location

Mylan Investigational Site

Tustin, California, 92780, United States

Location

Mylan Investigational Site

Walnut Creek, California, 94598, United States

Location

Mylan Investigational Site

Bradenton, Florida, 34208, United States

Location

Mylan Investigational Site

Cooper City, Florida, 33024, United States

Location

Mylan Investigational Site

Hialeah, Florida, 33012, United States

Location

Mylan Investigational Site

Hollywood, Florida, 33021, United States

Location

Mylan Investigational Site

Miami, Florida, 33142, United States

Location

Mylan Investigational Site

Miami, Florida, 33156, United States

Location

Mylan Investigational Site

New Port Richey, Florida, 34652, United States

Location

Mylan Investigational Site

Palm Harbor, Florida, 34684, United States

Location

Mylan Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Mylan Investigational Site

Atlanta, Georgia, 30318, United States

Location

Mylan Investigational Site

Columbus, Georgia, 31904, United States

Location

Mylan Investigational Site

Honolulu, Hawaii, 96814, United States

Location

Mylan Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Mylan Investigational Site

Crystal Lake, Illinois, 60012, United States

Location

Mylan Investigational Site

LaGrange, Illinois, 60525, United States

Location

Mylan Investigational Site

Springfield, Illinois, 62704, United States

Location

Mylan Investigational Site

Anderson, Indiana, 46011, United States

Location

Mylan Investigational Site

Muncie, Indiana, 47304, United States

Location

Mylan Investigational Site

Council Bluffs, Iowa, 51501, United States

Location

Mylan Investigational Site

Des Moines, Iowa, 50314, United States

Location

Mylan Investigational Site

Overland Park, Kansas, 66210, United States

Location

Mylan Investigational Site

Topeka, Kansas, 66606, United States

Location

Mylan Investigational Site

Lexington, Kentucky, 40503, United States

Location

Mylan Investigational Site

Billings, Montana, 59101, United States

Location

Mylan Investigational Site

Omaha, Nebraska, 68114, United States

Location

Mylan Investigational Site

Omaha, Nebraska, 68131, United States

Location

Mylan Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Mylan Investigational Site

Albany, New York, 12206, United States

Location

Mylan Investigational Site

Mineola, New York, 11501, United States

Location

Mylan Investigational Site

Staten Island, New York, 10301, United States

Location

Mylan Investigational Site

Syracuse, New York, 13210, United States

Location

Mylan Investigational Site

Asheville, North Carolina, 28803, United States

Location

Mylan Investigational Site

Burlington, North Carolina, 27215, United States

Location

Mylan Investigational Site

Greensboro, North Carolina, 27408, United States

Location

Mylan Investigational Site

Greenville, North Carolina, 27834, United States

Location

Mylan Investigational Site

Hickory, North Carolina, 28601, United States

Location

Mylan Investigational Site

Morehead City, North Carolina, 28557, United States

Location

Mylan Investigational Site

Wilmington, North Carolina, 28401, United States

Location

Mylan Investigational Site

Cincinnati, Ohio, 45236, United States

Location

Mylan Investigational Site

Mentor, Ohio, 44060, United States

Location

Mylan Investigational Site

Bend, Oregon, 97701, United States

Location

Mylan Investigational Site

Corvallis, Oregon, 97330, United States

Location

Mylan Investigational Site

Chattanooga, Tennessee, 37411, United States

Location

Mylan Investigational Site

Memphis, Tennessee, 38119, United States

Location

Mylan Investigational Site

Austin, Texas, 78731, United States

Location

Mylan Investigational Site

Dallas, Texas, 75231, United States

Location

Mylan Investigational Site

El Paso, Texas, 79925, United States

Location

Mylan Investigational Site

Round Rock, Texas, 78681, United States

Location

Texas Diabetes & Endocrinology

Round Rock, Texas, 78681, United States

Location

Mylan Investigational Site

San Antonio, Texas, 78258, United States

Location

Mylan Investigational Site

Ogden, Utah, 84405, United States

Location

Mylan Investigational Site

Salt Lake City, Utah, 84102, United States

Location

Mylan Investigational Site

Salt Lake City, Utah, 84109, United States

Location

Mylan Investigational Site

Salt Lake City, Utah, 84121, United States

Location

Mylan Investigational Site

South Jordan, Utah, 84095, United States

Location

Mylan Investigational Site

Chesapeake, Virginia, 23321, United States

Location

Mylan Investigational Site

Manassas, Virginia, 20110, United States

Location

Mylan Investigational Site

Renton, Washington, 98057, United States

Location

Mylan Investigational Site

Tacoma, Washington, 98405, United States

Location

Mylan Investigational Site

Vancouver, Washington, 98664, United States

Location

Mylan Investigational Site

Red Deer, Alberta, T4N 6V7, Canada

Location

Mylan Investigational Site

Vancouver, British Columbia, V6E IM7, Canada

Location

Mylan Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Mylan Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

Mylan Investigational Site

Mirabel, Quebec, J7J 2K8, Canada

Location

Mylan Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

Mylan Investigational Site

Brno, 625 00, Czechia

Location

Mylan Investigational Site

Brno, 656 91, Czechia

Location

Mylan Investigational Site

Broumov, 55016, Czechia

Location

Mylan Investigational Site

Bruntál, 792 01, Czechia

Location

Mylan Investigational Site

České Budějovice, 370 00, Czechia

Location

Mylan Investigational Site

Olomouc, 77900, Czechia

Location

Mylan Investigational Site

Pardubice, 530 02, Czechia

Location

Mylan Investigational Site

Prague, 100 00, Czechia

Location

Mylan Investigational Site

Prague, 100 34, Czechia

Location

Mylan Investigational Site

Pärnu, 80018, Estonia

Location

Mylan Investigational Site

Tallinn, 13419, Estonia

Location

Mylan Investigational Site

Tartu, 51014, Estonia

Location

Mylan Investigational Site

Hohenmölsen, Anhalt, 06679, Germany

Location

Mylan Investigational Site

Wangen, Baden-Wurttemberg, 88239, Germany

Location

Mylan Investigational Site

Aschaffenburg, Bavaria, 63739, Germany

Location

Mylan Investigational Site

Schweinfurt, Bavaria, 97421, Germany

Location

Mylan Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

Mylan Investigational Site

Münster, North Rhine-Westphalia, 48145, Germany

Location

Mylan Investigational Site

Sankt Ingbert, Saarland, 66386, Germany

Location

Mylan Investigational Site

Dresden, Saxony, 01307, Germany

Location

Mylan Investigational Site

Hamburg, 21073, Germany

Location

Mylan Investigational Site

Hamburg, 22603, Germany

Location

Mylan Investigational Site

Baja, 6500, Hungary

Location

Mylan Investigational Site

Budapest, 1033, Hungary

Location

Mylan Investigational Site

Budapest, 1083, Hungary

Location

Mylan Investigational Site

Budapest, 1088, Hungary

Location

Mylan Investigational Site

Eger, 3300, Hungary

Location

Mylan Investigational Site

Gyula, 5700, Hungary

Location

Mylan Investigational Site

Létavértes, 4281, Hungary

Location

Mylan Investigational Site

Makó, H-6900, Hungary

Location

Mylan Investigational Site

Miskolc, 3530, Hungary

Location

Mylan Investigational Site

Szeged, 6722, Hungary

Location

Mylan Investigational Site

Kuldīga, LC-3301, Latvia

Location

Mylan Investigational Site

Limbaži, 4001, Latvia

Location

Mylan Investigational Site

Ogre, LV-5001, Latvia

Location

Mylan Investigational Site

Riga, LV-1011, Latvia

Location

Mylan Investigational Site

Riga, LV-1050, Latvia

Location

Mylan Investigational Site

Riga, LV1002, Latvia

Location

Mylan Investigational Site

Sigulda, LV-3200, Latvia

Location

Mylan Investigational Site

Talsi, LV-3200, Latvia

Location

Mylan Investigational Site

Bacau, 600164, Romania

Location

Mylan Investigational Site

Baia Mare, 430222, Romania

Location

Mylan Investigational Site

Bucharest, 010825, Romania

Location

Mylan Investigational Site

Bucharest, 061072, Romania

Location

Mylan Investigational Site

Buzău, 120203, Romania

Location

Mylan Investigational Site

Cluj-Napoca, 400349, Romania

Location

Mylan Investigational Site

Galati, 800578, Romania

Location

Mylan Investigational Site

Iași, 700503, Romania

Location

Mylan Investigational Site

Oradea, 410169, Romania

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Mylan Investigational Site

Oradea, 410469, Romania

Location

Mylan Investigational Site

Timișoara, 300456, Romania

Location

Mylan Investigational Site

Banská Bystrica, 97517, Slovakia

Location

Mylan Investigational Site

Bardejov, 08501, Slovakia

Location

Mylan Investigational Site

Bratislava, 82106, Slovakia

Location

Mylan Investigational Site

Bratislava, 83331, Slovakia

Location

Mylan Investigational Site

Bratislava, 85101, Slovakia

Location

Mylan Investigational Site

Dolný Kubín, 02601, Slovakia

Location

Mylan Investigational Site

Košice, 04011, Slovakia

Location

Mylan Investigational Site

Levice, 93401, Slovakia

Location

Mylan Investigational Site

Ľubochňa, 03491, Slovakia

Location

Mylan Investigational Site

Nové Mesto nad Váhom, 91501, Slovakia

Location

Mylan Investigational Site

Nové Zámky, 94002, Slovakia

Location

Mylan Investigational Site

Prešov, 08001, Slovakia

Location

Mylan Investigational Site

Prievidza, 97101, Slovakia

Location

Mylan Investigational Site

Pruské, 01852, Slovakia

Location

Mylan Investigational Site

Rimavská Sobota, 97901, Slovakia

Location

Mylan Investigational Site

Sabinov, 08301, Slovakia

Location

Mylan Investigational Site

Skalica, 90901, Slovakia

Location

Mylan Investigational Site

Štúrovo, 943 01, Slovakia

Location

Mylan Investigational Site

Trebišov, 07501, Slovakia

Location

Mylan Investigational Site

Žilina, 01001, Slovakia

Location

Mylan Investigational Site

Bloemfontein, Free State, 9301, South Africa

Location

Mylan Investigational Site

Johannesburg, Gauteng, 1501, South Africa

Location

Mylan Investigational Site

Johannesburg, Gauteng, 1619, South Africa

Location

Mylan Investigational Site

Johannesburg, Gauteng, 2198, South Africa

Location

Mylan Investigational Site

Krugersdorp, Gauteng, 1739, South Africa

Location

Mylan Investigational Site

Pretoria, Gauteng, 0002, South Africa

Location

Mylan Investigational Site

Durban, KwaZulu-Natal, 4091, South Africa

Location

Mylan Investigational Site

Cape Town, Western Cape, 7570, South Africa

Location

Mylan Investigational Site

Cape Town, Western Cape, 7580, South Africa

Location

Mylan Investigational Site

Cape Town, Western Cape, 7708, South Africa

Location

Mylan Investigational Site

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Mylan Investigational Site

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Mylan Investigational Site

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34174848 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: David Gillogly, Head of Global Clinical Operations
• Organization: Mylan Inc.

david.gillogly@mylan.com

+1 (724) 4856581

Study Officials

• Thomas Blevins, MD

  Texas Diabetes & Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 3, 2022
• Results First Posted: March 9, 2020

Record last verified: 2022-03

Locations

HU (10); LA (8); RO (11); US (72); CZ (9); CA (6); DE (10); SL (20); ES (3); ZA (10); GB (3)