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

Use our guide to learn which trials are right for you!

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
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Avon, Indiana 46123
?
mi
from
Avon, IN
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Berlin, New Jersey 08009
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Blackfoot, Idaho 83221
?
mi
from
Blackfoot, ID
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chiefland, Florida 32626
?
mi
from
Chiefland, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Council Bluffs, Iowa 51501
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
Edinburg, Texas 78539
?
mi
from
Edinburg, TX
Click here to add this to my saved trials
Elizabeth, New Jersey 07202
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Escondido, California 92025
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Honolulu, Hawaii 96814
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Johns Creek, Georgia 30097
?
mi
from
Johns Creek, GA
Click here to add this to my saved trials
Las Vegas, Nevada 89128
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Midland, Texas 79707
?
mi
from
Midland, TX
Click here to add this to my saved trials
Mission Viejo, California 92691
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
Moncks Corner, South Carolina 29461
?
mi
from
Moncks Corner, SC
Click here to add this to my saved trials
Nashua, New Hampshire 03063
?
mi
from
Nashua, NH
Click here to add this to my saved trials
New Braunfels, Texas 78130
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
North Miami, Florida 33181
?
mi
from
North Miami, FL
Click here to add this to my saved trials
North Richland Hills, Texas 76180
?
mi
from
North Richland Hills, TX
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Peoria, Illinois 61615
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Phoenix, Arizona 85053
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Charlotte, Florida 33952
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Reading, Pennsylvania 19609
?
mi
from
Reading, PA
Click here to add this to my saved trials
Roseville, California 95661
?
mi
from
Roseville, CA
Click here to add this to my saved trials
Saint Peters, Missouri 63376
?
mi
from
Saint Peters, MO
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
San Antonio, Texas 78224
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Skokie, Illinois 60077
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Sugar Land, Texas 77479
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
Surrey, British Columbia
?
mi
from
Surrey,
Click here to add this to my saved trials
Troy, Michigan 48098
?
mi
from
Troy, MI
Click here to add this to my saved trials
Tucson, Arizona 85704
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials