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

Condition(s) targeted: Type 1 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 (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.

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 1 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:

Immunogenicity: Change from baseline in titer and incidence of ADA

Rate per 30 days of hypoglycemic events

Insulin dose per body weight (U/kg)

Detailed description: 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®.

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

Criteria:

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.

Mylan Investigational Site, Brno 625 00, Czech Republic

Mylan Investigational Site, Brno 656 91, Czech Republic

Mylan Investigational Site, Broumov 55016, Czech Republic

Mylan Investigational Site, Bruntal 792 01, Czech Republic

Mylan Investigational Site, Ceske Budejovice 370 00, Czech Republic

Mylan Investigational Site, Olomouc 77900, Czech Republic

Mylan Investigational Site, Pardubice 530 02, Czech Republic

Mylan Investigational Site, Praha 10 100 00, Czech Republic

Mylan Investigational Site, Praha 10 100 34, Czech Republic

Mylan Investigational Site, Parnu 80018, Estonia

Mylan Investigational Site, Tallinn 13419, Estonia

Mylan Investigational Site, Tartu 51014, Estonia

Mylan Investigational Site, Hamburg 21073, Germany

Mylan Investigational Site, Hamburg 22603, Germany

Mylan Investigational Site, Baja 6500, Hungary

Mylan Investigational Site, Budapest 1033, Hungary

Mylan Investigational Site, Budapest 1083, Hungary

Mylan Investigational Site, Budapest 1088, Hungary

Mylan Investigational Site, Eger 3300, Hungary

Mylan Investigational Site, Gyula 5700, Hungary

Mylan Investigational Site, Letavertes 4281, Hungary

Mylan Investigational Site, Mako H-6900, Hungary

Mylan Investigational Site, Miskolc 3530, Hungary

Mylan Investigational Site, Szeged 6722, Hungary

Mylan Investigational Site, Kuldiga LC-3301, Latvia

Mylan Investigational Site, Limbazi 4001, Latvia

Mylan Investigational Site, Ogre LV-5001, Latvia

Mylan Investigational Site, Riga LV-1011, Latvia

Mylan Investigational Site, Riga LV-1050, Latvia

Mylan Investigational Site, Riga LV1002, Latvia

Mylan Investigational Site, Sigulda LV-3200, Latvia

Mylan Investigational Site, Talsi LV-3200, Latvia

Mylan Investigational Site, Bacau 600164, Romania

Mylan Investigational Site, Baia Mare 430222, Romania

Mylan Investigational Site, Bucuresti 010825, Romania

Mylan Investigational Site, Bucuresti 061072, Romania

Mylan Investigational Site, Buzau 120203, Romania

Mylan Investigational Site, Cluj Napoca 400349, Romania

Mylan Investigational Site, Galati 800578, Romania

Mylan Investigational Site, Iasi 700503, Romania

Mylan Investigational Site, Oradea 410469, Romania

Mylan Investigational Site, Oradea 410169, Romania

Mylan Investigational Site, Timisoara 300456, Romania

Mylan Investigational Site, Banska Bystrica 97517, Slovakia

Mylan Investigational Site, Bardejov 08501, Slovakia

Mylan Investigational Site, Bratislava 82106, Slovakia

Mylan Investigational Site, Bratislava 83331, Slovakia

Mylan Investigational Site, Bratislava 85101, Slovakia

Mylan Investigational Site, Dolny Kubin 02601, Slovakia

Mylan Investigational Site, Kosice 04011, Slovakia

Mylan Investigational Site, Levice 93401, Slovakia

Mylan Investigational Site, Lubochna 03491, Slovakia

Mylan Investigational Site, Nove Mesto nad Vahom 91501, Slovakia

Mylan Investigational Site, Nove Zamky 94002, Slovakia

Mylan Investigational Site, Presov 08001, Slovakia

Mylan Investigational Site, Prievidza 97101, Slovakia

Mylan Investigational Site, Pruske 01852, Slovakia

Mylan Investigational Site, Rimavska Sobota 97901, Slovakia

Mylan Investigational Site, Sabinov 08301, Slovakia

Mylan Investigational Site, Skalica 90901, Slovakia

Mylan Investigational Site, Sturovo 943 01, Slovakia

Mylan Investigational Site, Trebisov 07501, Slovakia

Mylan Investigational Site, Zilina 01001, Slovakia

Mylan Investigational Site, Swansea SA6 6NL, United Kingdom

Mylan Investigational Site, Red Deer, Alberta T4N 6V7, Canada

Mylan Investigational Site, Wangen im Allgau, Baden Wuerttemberg 88239, Germany

Mylan Investigational Site, Aschaffenburg, Bayern 63739, Germany

Mylan Investigational Site, Schweinfurt, Bayern 97421, Germany

Mylan Investigational Site, Vancouver, British Columbia V6E IM7, Canada

Mylan Investigational Site, Bells Garden, California 90201, United States

Mylan Investigational Site, Fresno, California 93720, United States

Mylan Investigational Site, Greenbrae, California 93720, United States

Mylan Investigational Site, La Jolla, California 92037, United States

Mylan Investigational Site, La Mesa, California 91942, United States

Mylan Investigational Site, Long Beach, California 90807, 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 91950, United States

Mylan Investigational Site, Northridge, California 91324, United States

Mylan Investigational Site, Tustin, California 92780, United States

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

Mylan Investigational Site, Plymouth, Devon PL6 8DH, United Kingdom

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, Hollywood, Florida 33021, 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, West Palm Beach, Florida 33401, United States

Mylan Investigational Site, Bloemfontein, Free State 9301, South Africa

Mylan Investigational Site, Johannesburg, Gauteng 2198, South Africa

Mylan Investigational Site, Johannesburg, Gauteng 1619, South Africa

Mylan Investigational Site, Johannesburg, Gauteng 1501, South Africa

Mylan Investigational Site, Krugersdorp, Gauteng 1739, South Africa

Mylan Investigational Site, Pretoria, Gauteng 0002, South Africa

Mylan Investigational Site, Atlanta, Georgia 30318, United States

Mylan Investigational Site, Columbus, Georgia 31904, United States

Mylan Investigational Site, Honolulu, Hawaii 96814, United States

Mylan Investigational Site, Frankfurt, Hessen 60596, Germany

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

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

Mylan Investigational Site, LaGrange, Illinois 60525, United States

Mylan Investigational Site, Springfield, Illinois 62704, United States

Mylan Investigational Site, Anderson, Indiana 46011, United States

Mylan Investigational Site, Muncie, Indiana 47304, United States

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

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

Mylan Investigational Site, Overland Park, Kansas 66210, United States

Mylan Investigational Site, Topeka, Kansas 66606, United States

Mylan Investigational Site, Lexington, Kentucky 40503, United States

Mylan Investigational Site, Durban, KwaZulu-Natal 4091, South Africa

Mylan Investigational Site, Leicester, Leicestershire LE5 4PW, United Kingdom

Mylan Investigational Site, Winnipeg, Manitoba R3E 3P4, Canada

Mylan Investigational Site, Billings, Montana 59101, United States

Mylan Investigational Site, Omaha, Nebraska 68114, United States

Mylan Investigational Site, Omaha, Nebraska 68131, United States

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

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

Mylan Investigational Site, Mineola, New York 11501, United States

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

Mylan Investigational Site, Syracuse, New York 13210, United States

Mylan Investigational Site, Muenster, Nordrhein Westfalen 48145, Germany

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

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

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

Mylan Investigational Site, Greenville, North Carolina 27834, 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, Mentor, Ohio 44060, United States

Mylan Investigational Site, Bend, Oregon 97701, United States

Mylan Investigational Site, Corvallis, Oregon 97330, United States

Mylan Investigational Site, Laval, Quebec H7T 2P5, Canada

Mylan Investigational Site, Mirabel, Quebec J7J 2K8, Canada

Mylan Investigational Site, Montreal, Quebec H3A 1A1, Canada

Mylan Investigational Site, Sankt Ingbert, Saarland 66386, Germany

Mylan Investigational Site, Dresden, Sachsen 01307, Germany

Mylan Investigational Site, Hohenmoelsen, Sachsen Anhalt 06679, Germany

Mylan Investigational Site, Chattanooga, Tennessee 37411, United States

Mylan Investigational Site, Memphis, Tennessee 38119, United States

Mylan Investigational Site, Austin, Texas 78731, United States

Mylan Investigational Site, Dallas, Texas 75231, United States

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

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

Texas Diabetes & Endocrinology, Round Rock, Texas 78681, United States

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

Mylan Investigational Site, Ogden, Utah 84405, 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, Salt Lake City, Utah 84121, 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, Renton, Washington 98057, United States

Mylan Investigational Site, Tacoma, Washington 98405, United States

Mylan Investigational Site, Vancouver, Washington 98664, United States

Mylan Investigational Site, Cape Town, Western Cape 7708, South Africa

Mylan Investigational Site, Cape Town, Western Cape 7570, South Africa

Mylan Investigational Site, Cape Town, Western Cape 7580, South Africa

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