EUCTR2015-005209-36-ITActive, not recruitingPhase 1
Efficacy and Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.A 52-week Randomised, Open-label, Active-controlled Trial - PIONEER 2 - vs. SGLT-2
OVO NORDISK. S.P.A.0 sites821 target enrollmentStarted: June 4, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 821
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. 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.
- •2. Male or female, age above or equal to 18 years at the time of signing informed consent.
- •3. Diagnosed with type 2 diabetes mellitus = 90 days prior to day of screening.
- •4. HbA1c of 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
- •5. Stable daily dose of metformin (= 1500 mg or maximum tolerated dose as documented in the subject medical record) = 90 days prior to the day of screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 612
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 204
Exclusion Criteria
- •1. 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.
- •2. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
- •3. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
- •4. History of pancreatitis (acute or chronic).
- •5. 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).
- •6. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
- •7. Subjects presently classified as being in New York Heart Association Class IV.
- •8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •9. Subjects with ALT > 2.5 x upper normal limit.
- •10. Renal impairment defined as Estimated Glomerular Filtration Rate < 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
- •11. 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 = 14 days.
- •12. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
- •13. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
- •14. History of diabetic ketoacidosis.
Investigators
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