Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:September 21, 2015
End Date:October 13, 2016

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This trial is conducted globally. The aim of this trial is to investigate dose-finding of
semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects
with type 2 diabetes


Inclusion Criteria:

- Male or female, age at least 18 years at the time of signing informed consent.

- Subjects should be on stable diabetes treatment consisting of diet and exercise with
or without metformin (at least 1500 mg daily or maximum tolerated dose documented in
the patient medical record) for at least 90 days prior to screening

- HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)

- BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Exclusion Criteria:

- Simultaneous participation in any other clinical trial of an investigational medicinal
product

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using adequate contraceptive methods throughout the
trial including the 7 weeks follow-up period (adequate contraceptive measures as
required by local regulation or practice). Germany: Only highly effective methods of
birth control are accepted (i.e. one that results in less than 1% per year failure
rate when used consistently and correctly such as implants, injectables, combined oral
contraceptives, some intrauterine device), or sexual abstinence or vasectomised
partner. United Kingdom: Adequate contraceptive measures are defined as established
use of oral, injected or implanted hormonal methods of contraception, placement of an
intrauterine device or intrauterine system, barrier methods of contraception (condom
or occlusive cap with spermicidal foam/gel/film/cream/suppository), female
sterilisation, male sterilisation (where partner is sole partner of subject), or true
abstinence (when in line with preferred and usual lifestyle)

- 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 screening (an exception
is short-term insulin treatment for acute illnesses for a total of below or equal to
14 days)

- Anticipated initiation or change in concomitant medications (for more than 14
consecutive days or on an frequent basis) known to affect weight or glucose metabolism
(e.g. orlistat, thyroid hormones, corticosteroids)

- History of pancreatitis (acute or chronic)

- Screening calcitonin above or equal to 50 ng/L

- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary
Thyroid Carcinoma (MTC)

- Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2
as per CKD-EPI (Chronic Kidney Disease Epidemiology)

- Within the past 180 days before screening any of the following: Myocardial infarction,
stroke or hospitalisation for unstable angina and/or transient ischemic attack

- Currently planned coronary, carotid or peripheral artery revascularisation

- Patients presently classified as being in New York Heart Association (NYHA) Class III
or IV
We found this trial at
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Boca Raton, Florida 33433
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Boston, Massachusetts 02115
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Bountiful, Utah 84010
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Bridgeton, Missouri 63044
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Buckley, Michigan 49620
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Carrollton, Texas 75007
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Charleston, South Carolina 29407
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Chattanooga, Tennessee 37404
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Cincinnati, Ohio 45229
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Clinton, Utah 84015
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Coronado, California 92118
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Corvallis, Oregon 97330
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Crestview Hills, Kentucky 41017
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