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Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

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

NCT02863419•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)
•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

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)

Locations (108)

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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

Key Dates

Start Date

August 10, 2016

Primary Completion Date

August 19, 2017

Completion Date

March 30, 2018

Last Updated

July 20, 2022

Enrollment

711

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

semaglutide

DRUG

liraglutide

DRUG

placebo

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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