Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:January 6, 2016
End Date:May 19, 2017

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Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on
to metformin in subjects with type 2 diabetes.


Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive)
- Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal
tolerated dose documented in the patient medical record) for 90 days prior to screening
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 measures as required by local regulation or practice) - Any condition, 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 in a period of 90 days before screening. An exception
is short-term insulin treatment for acute illness for a total of equal to or below 14 days
- History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50
ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary
Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60
mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) -
Subjects presently classified as being in New York Heart Association Class IV - Planned
coronary, carotid or peripheral artery revascularisation on the day of screening -
Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of
malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and
in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more
than 14 consecutive days or on a frequent basis) known to affect weight or glucose
metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
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