A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/21/2018
Start Date:January 8, 2016
End Date:October 3, 2018

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A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose
is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus
insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately
controlled with oral anti diabetics.


Inclusion Criteria: - Male or female, age greater than or equal to 18 years at the time of
signing informed consent - Subjects diagnosed with type 2 diabetes mellitus - HbA1c
7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis - Body mass
index greater than or equal to 20 kg/m^2 - Insulin naïve subjects; however short term
insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is
prior insulin treatment for gestational diabetes - Stable daily dose(s) including any of
the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening:
a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose
documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea,
glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum
approved dose according to local label or maximum tolerated dose as documented in subjects
medical record) Exclusion Criteria: - Screening calcitonin greater than or equal to 50 ng/L
- Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m^2
as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for
serum creatinine measurement on the day of screening - Impaired liver function, defined as
ALAT or ASAT greater than or equal to 2.5 times upper limit of normal - Family or personal
history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of
pancreatitis (acute or chronic) - Treatment with any medication for the indication of
diabetes or obesity other than stated in the inclusion criteria in a period of 90 days
before the day of screening - Anticipated initiation or change in concomitant medications
for more than 14 consecutive days or on a frequent basis known to affect weight or glucose
metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
We found this trial at
39
sites
Albuquerque, New Mexico 87102
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Avon, Indiana 46123
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Beaver, Pennsylvania 15009
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Beaver, PA
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Bermuda Dunes, California 92203
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Bermuda Dunes, CA
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Billings, Montana 59101
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Billings, MT
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Blackfoot, Idaho 83221
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Blackfoot, ID
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Boynton Beach, Florida 33472
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Boynton Beach, FL
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Buckley, Michigan 49620
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Buckley, MI
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Buenos Aires,
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Dallas, Texas 75231
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Dallas, TX
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Fresno, California 93702
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Fresno, CA
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Glendale, Arizona 85306
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Glendale, AZ
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Greer, South Carolina 29651
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Greer, SC
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Houston, Texas 77030
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Houston, TX
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Humboldt, Tennessee 38343
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Humboldt, TN
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Hyattsville, Maryland 20782
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Hyattsville, MD
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Irving, Texas 75061
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Irving, TX
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Katy, TX
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Kenosha, Wisconsin 53142
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Kenosha, WI
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Lake Worth, Florida 33461
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Lake Worth, FL
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Lancaster, California 93534
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Lancaster, CA
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Mason, OH
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Maumee, OH
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Metairie, Louisiana 70002
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Metairie, LA
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Miami, Florida 33136
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Miami, FL
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Midlothian, Virginia 23114
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Midlothian, VA
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Monterey, California 93940
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Nashua, New Hampshire 03063
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Nashua, NH
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New Windsor, New York 12553
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Phoenix, Arizona 85053
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Rockville, Maryland 20852
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Sacramento, California 95821
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Sacramento, CA
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San Antonio, Texas 78224
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Spring Valley, California 91978
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Spring Valley, CA
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Tuscumbia, Alabama 35674
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Tuscumbia, AL
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Ventura, California 93003
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Ventura, CA
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Walnut Creek, California 94598
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Walnut Creek, CA
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Waltham, Massachusetts 02453
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Waltham, MA
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