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

NCT ID: NCT02227875

Last Updated: 2022-03-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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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

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mylan's insulin Glargine

receive Mylan's insulin Glargine

Group Type EXPERIMENTAL

Mylan's insulin glargine

Intervention Type 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.

Lantus®

receive Lantus®

Group Type ACTIVE_COMPARATOR

Lantus®

Intervention Type 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.

Interventions

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Mylan's insulin glargine

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mylan GmbH

INDUSTRY

Sponsor Role collaborator

Mylan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Blevins, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Diabetes & Endocrinology

Locations

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Mylan Investigational Site

Chandler, Arizona, United States

Site Status

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

Long Beach, California, United States

Site Status

Mylan Investigational Site

Los Angeles, 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

Orange, California, United States

Site Status

Mylan Investigational Site

Palm Springs, California, United States

Site Status

Mylan Investigational Site

Spring Valley, 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

West Hills, 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

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

Pembroke Pines, Florida, United States

Site Status

Mylan Investigational Site

Port Charlotte, Florida, United States

Site Status

Mylan Investigational Site

West Palm Beach, Florida, United States

Site Status

Mylan Investigational Site

Winter Haven, Florida, United States

Site Status

Mylan Investigational Site

Columbus, Georgia, United States

Site Status

Mylan Investigational Site

Gainesville, 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

Chicago, Illinois, United States

Site Status

Mylan Investigational Site

Crystal Lake, 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

Council Bluffs, Iowa, United States

Site Status

Mylan Investigational Site

Des Moines, Iowa, United States

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Mylan Investigational Site

Augusta, Kansas, United States

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Mylan Investigational Site

Topeka, Kansas, United States

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Mylan Investigational Site

Wichita, Kansas, United States

Site Status

Mylan Investigational Site

Crestview Hills, Kentucky, United States

Site Status

Mylan Investigational Site

Lexington, Kentucky, United States

Site Status

Mylan Investigational Site

Waltham, Massachusetts, United States

Site Status

Mylan Investigational Site

Kansas City, Missouri, United States

Site Status

Mylan Investigational Site

St Louis, Missouri, United States

Site Status

Mylan Investigational Site

Billings, Montana, United States

Site Status

Mylan Investigational Site

Lincoln, Nebraska, 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

Las Vegas, Nevada, United States

Site Status

Mylan Investigational Site

Nashua, New Hampshire, United States

Site Status

Mylan Investigational Site

Albany, New York, United States

Site Status

Mylan Investigational Site

Hartsdale, New York, United States

Site Status

Mylan Investigational Site

Smithtown, New York, United States

Site Status

Mylan Investigational Site

Staten Island, 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

Cary, 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

Cleveland, Ohio, United States

Site Status

Mylan Investigational Site

Columbus, Ohio, United States

Site Status

Mylan Investigational Site

Bend, Oregon, United States

Site Status

Mylan Investigational Site

Charleston, South Carolina, United States

Site Status

Mylan Investigational Site

Greer, South Carolina, United States

Site Status

Mylan Investigational Site

Bristol, Tennessee, United States

Site Status

Mylan Investigational Site

Kingsport, 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

Corpus Christi, Texas, United States

Site Status

Mylan Investigational Site

Dallas, 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

Houston, Texas, United States

Site Status

Mylan Investigational Site

Houston, Texas, United States

Site Status

Mylan Investigational Site

McKinney, Texas, United States

Site Status

Mylan Investigational Site

Round Rock, Texas, United States

Site Status

Mylan Investigational Site

San Antonio, Texas, United States

Site Status

Mylan Investigational Site

Spring, Texas, United States

Site Status

Mylan Investigational Site

Victoria, 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

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Mylan Investigational Site

South Jordan, Utah, United States

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Mylan Investigational Site

Chesapeake, Virginia, United States

Site Status

Mylan Investigational Site

Manassas, Virginia, 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

Amman, , Jordan

Site Status

Mylan Investigational Site

Irbid, , Jordan

Site Status

Mylan Investigational Site

Banská Bystrica, , Slovakia

Site Status

Mylan Investigational Site

Bardejov, , Slovakia

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Mylan Investigational Site

Bratislava, , Slovakia

Site Status

Mylan Investigational Site

Dolný Kubín, , Slovakia

Site Status

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

Site Status

Mylan Investigational Site

Johannesburg, 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

Worcester, Western Cape, South Africa

Site Status

Mylan Investigational Site

Bloemfontein, , South Africa

Site Status

Mylan Investigational Site

Seoul, Gyeonggi-do, South Korea

Site Status

Mylan Investigational Site

Suwon, Gyeonggi-do, South Korea

Site Status

Mylan Investigational Site

Seoul, , South Korea

Site Status

Mylan Investigational Site

Kaohsiung City, , Taiwan

Site Status

Mylan Investigational Site

Taipei, , Taiwan

Site Status

Countries

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United States Jordan Slovakia South Africa South Korea Taiwan

References

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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

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MYL-GAI-3002

Identifier Type: -

Identifier Source: org_study_id

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