Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/4/2018
Start Date:December 2, 2013
End Date:June 15, 2015

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This trial is conducted in Asia, Europe and North America. The aim of the trial is to
investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects
with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.


Inclusion Criteria:

- - Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial

- - Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above
1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin
100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is
defined as unchanged medication and dose

- - HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)

- - Body mass index equal to or above 20 kg/m^2

Exclusion Criteria:

- - Any chronic disorder or severe disease which at the discretion of the investigator
might jeopardise subject's safety or compliance with the protocol

- - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
in a period of 90 days prior to screening. An exception is short-term treatment (equal
to or less than 7 days in total) with insulin in connection with intercurrent illness

- - Female who is pregnant, breast-feeding, intends to become pregnant or of
child-bearing potential not using adequate contraceptive methods (adequate
contraceptive measures as required by local regulations or practice)

- - History of chronic pancreatitis or idiopathic acute pancreatitis

- - Screening calcitonin value equal to or above 50 ng/L

- - Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia syndrome type 2

- - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin
cancer or squamous cell skin cancer)

- - Impaired liver function, defined as alanine aminotransferase equal to or above 2.5
times upper normal limit

- - Impaired renal function defined as estimated glomerular filtration rate 60
mL/min/1.73 m^2 per modification of diet in renal disease formula

- - Any episode of unstable angina, acute coronary event, cerebral stroke/transient
ischemic attack or other significant cardiovascular event as judged by the
investigator within 90 days prior to screening

- - Heart failure, New York Heart Association class IV

- - Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or
above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
We found this trial at
50
sites
Midland, Texas 79707
1195
mi
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Midland, TX
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110
mi
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Akron, OH
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Albany, New York 12208
513
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Albany, NY
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Arlington Heights, Illinois 60004
348
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Arlington Heights, IL
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Avon, Indiana 46123
179
mi
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Avon, IN
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Bangor, Maine 04401
798
mi
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Bangor, ME
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Berlin, New Jersey 08009
429
mi
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Berlin, NJ
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Blackfoot, Idaho 83221
1523
mi
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Blackfoot, ID
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Charlotte, North Carolina 28277
348
mi
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Charlotte, NC
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Chicago, Illinois 60612
274
mi
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Chicago, IL
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Chiefland, Florida 32626
724
mi
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Chiefland, FL
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Colorado Springs, Colorado 80910
1161
mi
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Colorado Springs, CO
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Council Bluffs, Iowa 51501
678
mi
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Council Bluffs, IA
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Edinburg, Texas 78539
1284
mi
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Edinburg, TX
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Elizabeth, New Jersey 07202
?
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Elizabeth, NJ
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Escondido, California 92025
1936
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Escondido, CA
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Evansville, Indiana 47714
278
mi
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Evansville, IN
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Fall River, Massachusetts 02720
?
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Fall River, MA
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Fort Lauderdale, Florida 33316
972
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Fort Lauderdale, FL
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Fort Worth, Texas 76104
937
mi
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Fort Worth, TX
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Hialeah, Florida 33012
987
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Hialeah, FL
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Honolulu, Hawaii 96814
4501
mi
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Honolulu, HI
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Houston, Texas 77030
995
mi
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Houston, TX
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Jacksonville, Florida 32207
672
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Jacksonville, FL
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Johns Creek, Georgia 30097
399
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Johns Creek, GA
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Las Vegas, Nevada 89128
1762
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Las Vegas, NV
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Memphis, Tennessee 38119
503
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Memphis, TN
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Miami, Florida 33136
992
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Miami, FL
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Mission Viejo, California 92691
1954
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Mission Viejo, CA
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Moncks Corner, South Carolina 29461
496
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Moncks Corner, SC
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Nashua, New Hampshire 03063
629
mi
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Nashua, NH
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New Braunfels, Texas 78130
1108
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New Braunfels, TX
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North Miami, Florida 33181
?
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North Miami, FL
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North Richland Hills, Texas 76180
929
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North Richland Hills, TX
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Orangeburg, South Carolina 29118
463
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Orangeburg, SC
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Peoria, Illinois 61615
349
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Peoria, IL
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Phoenix, Arizona 85053
1662
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Port Charlotte, Florida 33952
899
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Port Charlotte, FL
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Reading, Pennsylvania 19609
375
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Reading, PA
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Roseville, California 95661
2028
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Roseville, CA
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Saint Peters, Missouri 63376
413
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Saint Peters, MO
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Salisbury, North Carolina 28144
327
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Salisbury, NC
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San Antonio, Texas 78224
1138
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San Antonio, TX
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Skokie, Illinois 60077
285
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Skokie, IL
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Spokane, Washington 99202
1776
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Spokane, WA
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Sugar Land, Texas 77479
1009
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Surrey, British Columbia
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Troy, Michigan 48098
303
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Troy, MI
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Tucson, Arizona 85704
1638
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Virginia Beach, Virginia 23454
437
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Virginia Beach, VA
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