Status:
COMPLETED
A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. Th...
Eligibility Criteria
Inclusion
- 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 Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent.
- For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus
- HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).
Exclusion
- \- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method.
- Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.
- History or presence of pancreatitis (acute or chronic).
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Any of the following: myocardial infarction, stroke, hospitalization 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.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI).
- Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
521 Patients enrolled
Trial Details
Trial ID
NCT04109547
Start Date
October 1 2019
End Date
October 27 2021
Last Update
September 19 2024
Active Locations (66)
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1
Bouzareah Diabetic House Algiers Algeria
Algiers, Algeria, 16000
2
UH of Douera
Algiers, Algeria, 16049
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230061
4
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China, 101200