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 | Completed Phase 3 Results

• 1 other identifier: MYL-GAI-3002
• Study Type: interventional
• Target: 560
• Locations: 6 countries
• Sites: 120

Brief 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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to 24 Weeks

  24 weeks

Secondary Outcomes (6)

• Rate of Hypoglycemic Events Per 30 Days

  Baseline and up to 24 weeks

• Hypoglycemia Occurrence

  24 weeks

• Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time

  Week 12 and week 24

• Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time

  week 12 and week 24

• Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time

  week 12 and week 24

Study Arms (2)

Mylan's insulin Glargine

EXPERIMENTAL

receive Mylan's insulin Glargine

Drug: Mylan's insulin glargine

Lantus®

ACTIVE COMPARATOR

receive Lantus®

Drug: Lantus®

Interventions

Mylan's insulin glargine DRUG

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.

Mylan's insulin Glargine

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.

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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (120)

Mylan Investigational Site

Chandler, Arizona, 85224, United States

Location

Mylan Investigational Site

Bell Gardens, California, 90201, United States

Location

Mylan Investigational Site

Fresno, California, 93720, United States

Location

Mylan Investigational Site

Greenbrae, California, 94904, United States

Location

Mylan Investigational Site

Long Beach, California, 90807, United States

Location

Mylan Investigational Site

Los Angeles, California, 90057, United States

Location

Mylan Investigational Site

Los Gatos, California, 95032, United States

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Mylan Investigational Site

Mission Hills, California, 91345, United States

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Mylan Investigational Site

National City, California, 47304, United States

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Mylan Investigational Site

Northridge, California, 91324, United States

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Mylan Investigational Site

Orange, California, 92868, United States

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Mylan Investigational Site

Palm Springs, California, 92262, United States

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Mylan Investigational Site

Spring Valley, California, 91978, United States

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Mylan Investigational Site

Tustin, California, 92780, United States

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Mylan Investigational Site

Walnut Creek, California, 94598, United States

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Mylan Investigational Site

West Hills, California, 91307, United States

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Mylan Investigational Site

Bradenton, Florida, 34208, United States

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Mylan Investigational Site

Cooper City, Florida, 33024, United States

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Mylan Investigational Site

Hialeah, Florida, 33012, United States

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Mylan Investigational Site

Miami, Florida, 33142, United States

Location

Mylan Investigational Site

Miami, Florida, 33156, United States

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Mylan Investigational Site

New Port Richey, Florida, 34652, United States

Location

Mylan Investigational Site

Palm Harbor, Florida, 34684, United States

Location

Mylan Investigational Site

Pembroke Pines, Florida, 33028, United States

Location

Mylan Investigational Site

Port Charlotte, Florida, 33952, United States

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Mylan Investigational Site

West Palm Beach, Florida, 33401, United States

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Mylan Investigational Site

Winter Haven, Florida, 33880, United States

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Mylan Investigational Site

Columbus, Georgia, 31904, United States

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Mylan Investigational Site

Gainesville, Georgia, 30501, United States

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Mylan Investigational Site

Honolulu, Hawaii, 96814, United States

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Mylan Investigational Site

Idaho Falls, Idaho, 83404, United States

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Mylan Investigational Site

Chicago, Illinois, 60616, United States

Location

Mylan Investigational Site

Crystal Lake, Illinois, 60012, United States

Location

Mylan Investigational Site

Springfield, Illinois, 62704, United States

Location

Mylan Investigational Site

Anderson, Indiana, 46011, United States

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Mylan Investigational Site

Council Bluffs, Iowa, 51501, United States

Location

Mylan Investigational Site

Des Moines, Iowa, 50314, United States

Location

Mylan Investigational Site

Augusta, Kansas, 67010, United States

Location

Mylan Investigational Site

Topeka, Kansas, 66606, United States

Location

Mylan Investigational Site

Wichita, Kansas, 67207, United States

Location

Mylan Investigational Site

Crestview Hills, Kentucky, 41017, United States

Location

Mylan Investigational Site

Lexington, Kentucky, 40503, United States

Location

Mylan Investigational Site

Waltham, Massachusetts, 02453, United States

Location

Mylan Investigational Site

Kansas City, Missouri, 64114, United States

Location

Mylan Investigational Site

St Louis, Missouri, 63128, United States

Location

Mylan Investigational Site

Billings, Montana, 59101, United States

Location

Mylan Investigational Site

Lincoln, Nebraska, 68516, 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, 89119, United States

Location

Mylan Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Mylan Investigational Site

Nashua, New Hampshire, 03063, United States

Location

Mylan Investigational Site

Albany, New York, 12206, United States

Location

Mylan Investigational Site

Hartsdale, New York, 10530, United States

Location

Mylan Investigational Site

Smithtown, New York, 11787, United States

Location

Mylan Investigational Site

Staten Island, New York, 10301, United States

Location

Mylan Investigational Site

Asheville, North Carolina, 28803, United States

Location

Mylan Investigational Site

Burlington, North Carolina, 27215, United States

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Mylan Investigational Site

Cary, North Carolina, 27513, United States

Location

Mylan Investigational Site

Greensboro, North Carolina, 27408, United States

Location

Mylan Investigational Site

Greenville, North Carolina, 28590, United States

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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

Cleveland, Ohio, 44122, United States

Location

Mylan Investigational Site

Columbus, Ohio, 43201, United States

Location

Mylan Investigational Site

Bend, Oregon, 97701, United States

Location

Mylan Investigational Site

Charleston, South Carolina, 29407, United States

Location

Mylan Investigational Site

Greer, South Carolina, 29651, United States

Location

Mylan Investigational Site

Bristol, Tennessee, 34208, United States

Location

Mylan Investigational Site

Kingsport, Tennessee, 37660, United States

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Mylan Investigational Site

Memphis, Tennessee, 38119, United States

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Mylan Investigational Site

Austin, Texas, 78731, United States

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Mylan Investigational Site

Corpus Christi, Texas, 78404, United States

Location

Mylan Investigational Site

Dallas, Texas, 75230, United States

Location

Mylan Investigational Site

Dallas, Texas, 75231, United States

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Mylan Investigational Site

El Paso, Texas, 79925, United States

Location

Mylan Investigational Site

Houston, Texas, 77004, United States

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Mylan Investigational Site

Houston, Texas, 77095, United States

Location

Mylan Investigational Site

McKinney, Texas, 75070, United States

Location

Mylan Investigational Site

Round Rock, Texas, 78681, United States

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Mylan Investigational Site

San Antonio, Texas, 78258, United States

Location

Mylan Investigational Site

Spring, Texas, 77379, United States

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Mylan Investigational Site

Victoria, Texas, 77901, 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

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Mylan Investigational Site

Tacoma, Washington, 98405, United States

Location

Mylan Investigational Site

Vancouver, Washington, 98405, United States

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Mylan Investigational Site

Amman, Jordan

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Mylan Investigational Site

Irbid, Jordan

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Mylan Investigational Site

Banská Bystrica, Slovakia

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Mylan Investigational Site

Bardejov, Slovakia

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Mylan Investigational Site

Bratislava, Slovakia

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Mylan Investigational Site

Dolný Kubín, Slovakia

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Mylan Investigational Site

Košice, Slovakia

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Mylan Investigational Site

Levice, Slovakia

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Mylan Investigational Site

Sabinov, Slovakia

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Mylan Investigational Site

Stropkov, Slovakia

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Mylan Investigational Site

Šahy, Slovakia

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Mylan Investigational Site

Štúrovo, Slovakia

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Mylan Investigational Site

Trebišov, Slovakia

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Mylan Investigational Site

Trenčín, Slovakia

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Mylan Investigational Site

Žilina, Slovakia

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Mylan Investigational Site

Johannesburg, Gauteng, South Africa

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Mylan Investigational Site

Durban, KwaZulu-Natal, South Africa

Location

Mylan Investigational Site

Cape Town, Western Cape, 7646, South Africa

Location

Mylan Investigational Site

Cape Town, Western Cape, South Africa

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Mylan Investigational Site

Worcester, Western Cape, South Africa

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Mylan Investigational Site

Bloemfontein, South Africa

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Mylan Investigational Site

Seoul, Gyeonggi-do, South Korea

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Mylan Investigational Site

Suwon, Gyeonggi-do, South Korea

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Mylan Investigational Site

Seoul, 110744, South Korea

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Mylan Investigational Site

Kaohsiung City, Taiwan

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Mylan Investigational Site

Taipei, Taiwan

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 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: Keri L. Vaughan, Director Global Clinical Operations, General Medicine
• Organization: Mylan, Inc.

keri.vaughan@mylan.com

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: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 3, 2022
• Results First Posted: August 13, 2020

Record last verified: 2022-03

Locations

ZA (6); US (94); TW (2); JO (2); KR (3); SL (13)