Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02863419

Run by

Novo Nordisk A/S

People needed

711

Starts

2016-08-10

Expected to finish

2018-03-30

Last updated by the study team

2022-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Los Alamitos, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Denver, Colorado, United States
• Novo Nordisk Investigational Site — Hallandale, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Ocala, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Ormond Beach, Florida, United States
• Novo Nordisk Investigational Site — St. Petersburg, Florida, United States
• Novo Nordisk Investigational Site — West Palm Beach, Florida, United States
• Novo Nordisk Investigational Site — Peoria, Illinois, United States
• Novo Nordisk Investigational Site — Topeka, Kansas, United States
• Novo Nordisk Investigational Site — Slidell, Louisiana, United States
• Novo Nordisk Investigational Site — Butte, Montana, United States
• Novo Nordisk Investigational Site — Lebanon, New Hampshire, United States
• Novo Nordisk Investigational Site — Teaneck, New Jersey, United States
• Novo Nordisk Investigational Site — Albany, New York, United States
• Novo Nordisk Investigational Site — Mineola, New York, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — Morganton, North Carolina, United States
• Novo Nordisk Investigational Site — Wilmington, North Carolina, United States
• Novo Nordisk Investigational Site — Dublin, Ohio, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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