Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2018 |
Start Date: | August 10, 2016 |
End Date: | March 30, 2018 |
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety
of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes
Mellitus.
of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes
Mellitus.
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, age above or equal to 18 years at the time of signing informed
consent. For Japan only: Male or female, age at least 20 years at the time of signing
informed consent
- Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of
screening.
- HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)
- Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as
documented in the subject medical record) alone or in combination with a stable daily
dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days
prior to day of screening (fixed-dose combinations are allowed)
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).For certain
specific countries: Additional specific requirements apply
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or
compliance with the protocol
- Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary
Thyroid Carcinoma (MTC)
- History of pancreatitis (acute or chronic)
- History of major surgical procedures involving the stomach and potentially affecting
absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
gastric bypass surgery)
- Any of the following: myocardial infarction (MI), stroke or hospitalisation 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 (NYHA) Class IV
- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
- Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)
- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60
mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
(CKD-EPI)
- 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 the day of screening.
An exception is short-term insulin treatment for acute illness for a total of below or
equal to 14 days
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or dilated fundoscopy performed within 90 days prior to randomisation
- History or presence of malignant neoplasms within the last 5 years (except basal and
squamous cell skin cancer and carcinoma in situ)
- History of diabetic ketoacidosis
We found this trial at
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