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

Condition(s) targeted: Type 2 Diabetes

Intervention: Mylan's insulin glargine (Drug); Lantus® (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Mylan Inc.

Official(s) and/or principal investigator(s):
Michael Ankersen, Study Director, Affiliation: Mylan Inc.

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c from baseline to 24 weeks

Secondary outcome:

Rate of hypoglycemic events per 30 days and hypoglycemia occurrence

Immunogenicity: Change in antibody titer

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Mylan Investigational Site, Amman, Jordan

Mylan Investigational Site, Irbid, Jordan

Mylan Investigational Site, Seoul 110744, Korea, Republic of

Mylan Investigational Site, Banska Bystrica, Slovakia

Mylan Investigational Site, Bardejov, Slovakia

Mylan Investigational Site, Bratislava, Slovakia

Mylan Investigational Site, Dolny Kubin, Slovakia

Mylan Investigational Site, Kosice, Slovakia

Mylan Investigational Site, Levice, Slovakia

Mylan Investigational Site, Sabinov, Slovakia

Mylan Investigational Site, Sahy, Slovakia

Mylan Investigational Site, Stropkov, Slovakia

Mylan Investigational Site, Sturovo, Slovakia

Mylan Investigational Site, Trebisov, Slovakia

Mylan Investigational Site, Trencin, Slovakia

Mylan Investigational Site, Zilina, Slovakia

Mylan Investigational Site, Bloemfontein, South Africa

Mylan Investigational Site, Kaohsiung, Taiwan

Mylan Investigational Site, Taipei, Taiwan

Mylan Investigational Site, Chandler, Arizona 85224, United States

Mylan Investigational Site, Bell Gardens, California 90201, United States

Mylan Investigational Site, Fresno, California 93720, United States

Mylan Investigational Site, Greenbrae, California 94904, United States

Mylan Investigational Site, Long Beach, California 90807, United States

Mylan Investigational Site, Los Angeles, California 90057, United States

Mylan Investigational Site, Los Gatos, California 95032, United States

Mylan Investigational Site, Mission Hills, California 91345, United States

Mylan Investigational Site, National City, California 47304, United States

Mylan Investigational Site, Northridge, California 91324, United States

Mylan Investigational Site, Orange, California 92868, United States

Mylan Investigational Site, Palm Springs, California 92262, United States

Mylan Investigational Site, Spring Valley, California 91978, United States

Mylan Investigational Site, Tustin, California 92780, United States

Mylan Investigational Site, Walnut Creek, California 94598, United States

Mylan Investigational Site, West Hills, California 91307, United States

Mylan Investigational Site, Bradenton, Florida 34208, United States

Mylan Investigational Site, Cooper City, Florida 33024, United States

Mylan Investigational Site, Hileah, Florida 33012, United States

Mylan Investigational Site, Miami, Florida 33142, United States

Mylan Investigational Site, Miami, Florida 33156, United States

Mylan Investigational Site, New Port Richey, Florida 34652, United States

Mylan Investigational Site, Palm Harbor, Florida 34684, United States

Mylan Investigational Site, Pembroke Pines, Florida 33028, United States

Mylan Investigational Site, Port Charlotte, Florida 33952, United States

Mylan Investigational Site, West Palm Beach, Florida 33401, United States

Mylan Investigational Site, Winter Haven, Florida 33880, United States

Mylan Investigational Site, Johannesburg, Gauteng, South Africa

Mylan Investigational Site, Columbus, Georgia 31904, United States

Mylan Investigational Site, Gainesville, Georgia 30501, United States

Mylan Investigational Site, Seoul, Gyeonggi-do, Korea, Republic of

Mylan Investigational Site, Suwon-si, Gyeonggi-do, Korea, Republic of

Mylan Investigational Site, Honolulu, Hawaii 96814, United States

Mylan Investigational Site, Idaho Falls, Idaho 83404, United States

Mylan Investigational Site, Chicago, Illinois 60616, United States

Mylan Investigational Site, Crystal Lake, Illinois 60012, United States

Mylan Investigational Site, Springfield, Illinois 62704, United States

Mylan Investigational Site, Anderson, Indiana 46011, United States

Mylan Investigational Site, Council Bluffs, Iowa 51501, United States

Mylan Investigational Site, Des Moines, Iowa 50314, United States

Mylan Investigational Site, Augusta, Kansas 67010, United States

Mylan Investigational Site, Topeka, Kansas 66606, United States

Mylan Investigational Site, Wichita, Kansas 67207, United States

Mylan Investigational Site, Crestview Hills, Kentucky 41017, United States

Mylan Investigational Site, Lexington, Kentucky 40503, United States

Mylan Investigational Site, Durban, KwaZulu-Natal, South Africa

Mylan Investigational Site, Waltham, Massachusetts 02453, United States

Mylan Investigational Site, Kansas City, Missouri 64114, United States

Mylan Investigational Site, St Louis, Missouri 63128, United States

Mylan Investigational Site, Billings, Montana 59101, United States

Mylan Investigational Site, Lincoln, Nebraska 68516, United States

Mylan Investigational Site, Omaha, Nebraska 68114, United States

Mylan Investigational Site, Omaha, Nebraska 68131, United States

Mylan Investigational Site, Las Vegas, Nevada 89119, United States

Mylan Investigational Site, Las Vegas, Nevada 89128, United States

Mylan Investigational Site, Nashua, New Hampshire 03063, United States

Mylan Investigational Site, Albany, New York 12206, United States

Mylan Investigational Site, Hartsdale, New York 10530, United States

Mylan Investigational Site, Smithtown, New York 11787, United States

Mylan Investigational Site, Staten Island, New York 10301, United States

Mylan Investigational Site, Asheville, North Carolina 28803, United States

Mylan Investigational Site, Burlington, North Carolina 27215, United States

Mylan Investigational Site, Cary, North Carolina 27513, United States

Mylan Investigational Site, Greensboro, North Carolina 27408, United States

Mylan Investigational Site, Greenville, North Carolina 28590, United States

Mylan Investigational Site, Hickory, North Carolina 28601, United States

Mylan Investigational Site, Morehead City, North Carolina 28557, United States

Mylan Investigational Site, Wilmington, North Carolina 28401, United States

Mylan Investigational Site, Cincinnati, Ohio 45236, United States

Mylan Investigational Site, Cleveland, Ohio 44122, United States

Mylan Investigational Site, Columbus, Ohio 43201, United States

Mylan Investigational Site, Bend, Oregon 97701, United States

Mylan Investigational Site, Charleston, South Carolina 29407, United States

Mylan Investigational Site, Greer, South Carolina 29651, United States

Mylan Investigational Site, Bristol, Tennessee 34208, United States

Mylan Investigational Site, Kingsport, Tennessee 37660, United States

Mylan Investigational Site, Memphis, Tennessee 38119, United States

Mylan Investigational Site, Austin, Texas 78731, United States

Mylan Investigational Site, Corpus Christi, Texas 78404, United States

Mylan Investigational Site, Dallas, Texas 75230, United States

Mylan Investigational Site, Dallas, Texas 75231, United States

Mylan Investigational Site, El Paso, Texas 79925, United States

Mylan Investigational Site, Houston, Texas 77004, United States

Mylan Investigational Site, Houston, Texas 77095, United States

Mylan Investigational Site, McKinney, Texas 75070, United States

Mylan Investigational Site, Round Rock, Texas 78681, United States

Mylan Investigational Site, San Antonio, Texas 78258, United States

Mylan Investigational Site, Spring, Texas 77379, United States

Mylan Investigational Site, Victoria, Texas 77901, United States

Mylan Investigational Site, Ogden, Utah 84405, United States

Mylan Investigational Site, Salt Lake City, Utah 84121, United States

Mylan Investigational Site, Salt Lake City, Utah 84102, United States

Mylan Investigational Site, Salt Lake City, Utah 84109, United States

Mylan Investigational Site, South Jordan, Utah 84095, United States

Mylan Investigational Site, Chesapeake, Virginia 23321, United States

Mylan Investigational Site, Manassas, Virginia 20110, United States

Mylan Investigational Site, Tacoma, Washington 98405, United States

Mylan Investigational Site, Vancouver, Washington 98405, United States

Mylan Investigational Site, Cape Town, Western Cape, South Africa

Mylan Investigational Site, Cape Town, Western Cape 7646, South Africa

Mylan Investigational Site, Worcester, Western Cape, South Africa

Starting date: August 2014
Last updated: June 23, 2015