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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:3/4/2017
Start Date:August 2014
End Date:July 2016

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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

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.

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®.

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.
We found this trial at
69
sites
Dallas, Texas 75231
1225
mi
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Dallas, TX
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Albany, New York 12206
2440
mi
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Albany, NY
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Anderson, Indiana 46011
1819
mi
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Anderson, IN
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Asheville, North Carolina 28803
2002
mi
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Asheville, NC
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Atlanta, Georgia 30318
1919
mi
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Atlanta, GA
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Austin, Texas 78731
1208
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Austin, TX
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Bells Garden, California 90201
?
mi
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Bells Garden, CA
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Bend, Oregon 97701
712
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Bend, OR
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Billings, Montana 59101
951
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Billings, MT
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Bradenton, Florida 34208
2140
mi
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Bradenton, FL
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Burlington, North Carolina 27215
2171
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Burlington, NC
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Chattanooga, Tennessee 37411
1853
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Chattanooga, TN
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Chesapeake, Virginia 23321
2341
mi
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Chesapeake, VA
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Cincinnati, Ohio 45236
1882
mi
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Cincinnati, OH
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Columbus, Georgia 31904
1902
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from 91732
Columbus, GA
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Cooper City, Florida 33024
2309
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Cooper City, FL
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Corvallis, Oregon 97330
776
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Corvallis, OR
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Council Bluffs, Iowa 51501
1304
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Council Bluffs, IA
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Crystal Lake, Illinois 60012
1573
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Crystal Lake, IL
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Des Moines, Iowa 50314
1423
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Des Moines, IA
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El Paso, Texas 79925
686
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El Paso, TX
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Fresno, California 93720
209
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Fresno, CA
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Greenbrae, California 94904
367
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Greenbrae, CA
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Greensboro, North Carolina 27408
2151
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Greensboro, NC
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Greenville, North Carolina 27834
2290
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Greenville, NC
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Hickory, North Carolina 28601
2069
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Hickory, NC
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Hileah, Florida 33012
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Hileah, FL
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Hollywood, Florida 33021
2318
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Hollywood, FL
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Honolulu, Hawaii 96814
2573
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Honolulu, HI
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Idaho Falls, Idaho 83404
724
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Idaho Falls, ID
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La Jolla, California 92037
16
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La Jolla, CA
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La Mesa, California 91942
106
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La Mesa, CA
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LaGrange, Illinois 60525
1716
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LaGrange, IL
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Las Vegas, Nevada 89128
217
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Las Vegas, NV
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Lexington, Kentucky 40503
1882
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Lexington, KY
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Long Beach, California 90807
23
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Long Beach, CA
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Los Gatos, California 95032
311
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Los Gatos, CA
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Manassas, Virginia 20110
2258
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Manassas, VA
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Memphis, Tennessee 38119
1586
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Memphis, TN
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Mentor, Ohio 44060
2051
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Mentor, OH
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Miami, Florida 33142
2322
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Miami, FL
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Mineola, New York 11501
2451
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Mineola, NY
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Mission Hills, California 91345
28
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Mission Hills, CA
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Morehead City, North Carolina 28557
2337
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Morehead City, NC
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Muncie, Indiana 47304
1835
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Muncie, IN
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National City, California 91950
109
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National City, CA
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New Port Richey, Florida 34652
2114
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New Port Richey, FL
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Northridge, California 91324
31
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Northridge, CA
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Ogden, Utah 84405
593
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Ogden, UT
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Omaha, Nebraska 68114
1301
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Omaha, NE
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Overland Park, Kansas 66210
1335
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Palm Harbor, Florida 34684
2115
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Palm Harbor, FL
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Red Deer, Alberta
1274
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Red Deer,
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Renton, Washington 98057
951
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Renton, WA
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Round Rock, Texas 78681
1208
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Round Rock, TX
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Round Rock, Texas 78681
1210
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Round Rock, TX
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Salt Lake City, Utah 84102
570
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Salt Lake City, UT
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San Antonio, Texas 78258
1188
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San Antonio, TX
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South Jordan, Utah 84095
558
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South Jordan, UT
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Springfield, Illinois 62704
1608
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Springfield, IL
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Staten Island, New York 10301
2426
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Staten Island, NY
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Syracuse, New York 13210
2319
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Tacoma, Washington 98405
939
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Tacoma, WA
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Topeka, Kansas 66606
1282
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Topeka, KS
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Tustin, California 92780
25
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Tustin, CA
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Vancouver, Washington 98664
835
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Vancouver, WA
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Walnut Creek, California 94598
354
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Walnut Creek, CA
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West Palm Beach, Florida 33401
2304
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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