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
Chiefland, Florida 32626
2078
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Chiefland, FL
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2040
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Akron, OH
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Albany, New York 12208
2438
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Albany, NY
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Arlington Heights, Illinois 60004
1610
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Arlington Heights, IL
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Avon, Indiana 46123
1780
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Avon, IN
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Bangor, Maine 04401
2685
mi
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Bangor, ME
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Berlin, New Jersey 08009
2388
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Berlin, NJ
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Blackfoot, Idaho 83221
699
mi
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Blackfoot, ID
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Charlotte, North Carolina 28277
2101
mi
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Charlotte, NC
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Chicago, Illinois 60612
1728
mi
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Chicago, IL
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Colorado Springs, Colorado 80910
804
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Colorado Springs, CO
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Council Bluffs, Iowa 51501
1304
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Council Bluffs, IA
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Edinburg, Texas 78539
1298
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
84
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Escondido, CA
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Evansville, Indiana 47714
1716
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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
2317
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Fort Lauderdale, FL
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Fort Worth, Texas 76104
1195
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Fort Worth, TX
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Hialeah, Florida 33012
2314
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Hialeah, FL
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Honolulu, Hawaii 96814
2572
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Honolulu, HI
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Houston, Texas 77030
1357
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Houston, TX
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Jacksonville, Florida 32207
2131
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Jacksonville, FL
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Johns Creek, Georgia 30097
1872
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Johns Creek, GA
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Las Vegas, Nevada 89128
213
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Las Vegas, NV
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Memphis, Tennessee 38119
1598
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Memphis, TN
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Miami, Florida 33136
2321
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Miami, FL
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Midland, Texas 79707
933
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Midland, TX
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Mission Viejo, California 92691
38
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Mission Viejo, CA
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Moncks Corner, South Carolina 29461
2174
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Moncks Corner, SC
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Nashua, New Hampshire 03063
2556
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Nashua, NH
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New Braunfels, Texas 78130
1203
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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
1198
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North Richland Hills, TX
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Orangeburg, South Carolina 29118
2122
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Peoria, Illinois 61615
1618
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Peoria, IL
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Phoenix, Arizona 85053
343
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Phoenix, AZ
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Port Charlotte, Florida 33952
2181
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Port Charlotte, FL
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Reading, Pennsylvania 19609
2333
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Reading, PA
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Roseville, California 95661
369
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Roseville, CA
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Saint Peters, Missouri 63376
1550
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Saint Peters, MO
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Salisbury, North Carolina 28144
2117
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Salisbury, NC
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San Antonio, Texas 78224
1188
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San Antonio, TX
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Skokie, Illinois 60077
1724
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Skokie, IL
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Spokane, Washington 99202
939
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Sugar Land, Texas 77479
1345
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Surrey, British Columbia
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Surrey,
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Troy, Michigan 48098
1831
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Troy, MI
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Tucson, Arizona 85704
423
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Tucson, AZ
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Virginia Beach, Virginia 23454
2354
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Virginia Beach, VA
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