Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:March 15, 2017
End Date:August 6, 2018

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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare
the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose
co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or
sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2
diabetes. Subjects will remain on their pre-trial medication.


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

- Male or female, above or equal to 18 years at the time of signing informed consent.
For Japan only: Male or female, age equal to or above 20 years at the time of signing
informed consent

- Diagnosed with type 2 diabetes mellitus

- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)

- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including
fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500
mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of
screening. All medications in compliance with current local label

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using an adequate contraceptive method (adequate
contraceptive measure as required by local regulation or practice)

- Any disorder which in the investigator's opinion might jeopardise subject's safety or
compliance with the protocol

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria within the past 90 days prior to the day of
screening. However, short term insulin treatment for a maximum of 14 days prior to the
day of screening is allowed

- Subjects with alanine aminotransferase above 2.5 x upper normal limit

- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative

- History or presence of pancreatitis (acute or chronic)

- History of diabetic ketoacidosis

- Any of the following: myocardial infarction, stroke, hospitalization for unstable
angina or transient ischaemic attack within the past 180 days prior to the day of
screening

- Subjects presently classified as being in New York Heart Association Class IV

- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening

- Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below
60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass
spectrometry for serum creatinine measured at screening

- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or dilated fundoscopy performed within the past 90 days prior to
randomisation

- Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed
We found this trial at
42
sites
Baltimore, Maryland 21229
340
mi
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Baltimore, MD
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Albany, New York 12208
513
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Andalusia, Alabama 36420
628
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Andalusia, AL
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Anniston, Alabama 36207
462
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Anniston, AL
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Arlington, Texas 76012
928
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Arlington, TX
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Austin, Texas 78731
1065
mi
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Austin, TX
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Beaver, Pennsylvania 15009
151
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Beaver, PA
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Charlotte, North Carolina 28277
348
mi
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Charlotte, NC
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Chesapeake, Virginia 23321
418
mi
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Chesapeake, VA
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Dallas, Texas 75231
905
mi
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Dallas, TX
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Edgewater, Florida 32132
767
mi
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Edgewater, FL
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Gastonia, North Carolina 28054
340
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Gastonia, NC
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Glendale, Arizona 85306
1662
mi
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Glendale, AZ
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Greenville, North Carolina 27834
430
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Greenville, NC
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Houston, Texas 77030
995
mi
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Houston, TX
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Hutchinson, Kansas 67502
809
mi
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Hutchinson, KS
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Irving, Texas 75061
914
mi
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Irving, TX
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Jefferson City, Missouri 65109
498
mi
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Jefferson City, MO
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Kinston, North Carolina 28501
440
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Kinston, NC
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La Jolla, California 92037
1954
mi
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La Jolla, CA
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Lawrenceville, Georgia 30046
418
mi
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Lawrenceville, GA
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Lexington, Kentucky 40503
157
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Lexington, KY
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Lincoln, California 95648
2027
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Lincoln, CA
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Little Rock, Arkansas 72202
623
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Little Rock, AR
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Maitland, Florida 32751
788
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Maitland, FL
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McMurray, Pennsylvania 15317
156
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McMurray, PA
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Morehead City, North Carolina 28557
500
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Morehead City, NC
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1514
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Murray, UT
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Norman, Oklahoma 73069
853
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Norman, OK
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Northridge, California 91325
1981
mi
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Northridge, CA
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Olympia, Washington 98502
2033
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Olympia, WA
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Phoenix, Arizona 85053
1662
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Pittsburgh, Pennsylvania 15224
163
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Pittsburgh, PA
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?
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Saint Stefan,
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Shavano Park, Texas 78231
1133
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Shavano Park, TX
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Smithtown, New York 11787
519
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Smithtown, NY
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Sugar Land, Texas 77479
1009
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Sugar Land, TX
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Tempe, Arizona 85283
1657
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Tempe, AZ
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Troy, Michigan 48098
303
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Troy, MI
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Victoria, Texas 77901
1105
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Victoria, TX
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West Seneca, New York 14224
295
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West Seneca, NY
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Woodstock, Georgia 30189
413
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Woodstock, GA
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