ASCEND PLUS - a research study to test whether a treatment called oral semaglutide can protect people with type 2 diabetes from heart attacks, strokes, and other health problems

Phase 4

• Conditions: Type 2 diabetes. The most common type of diabetes - a disease that occurs when your blood glucose (also called blood sugar) is too high.; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN76193287
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-27
• Last Update Posted: 27 March 2023
• Study Completion: 2048-08-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

1. Adults aged at least 55 years
2. Type 2 diabetes mellitus

Exclusion Criteria

1. Myocardial Infarction
2. Stroke
3. Current or planned treatment with a GLP-1 RA
4. Previous hypersensitivity to or intolerance of GLP-1 RA therapy
5. Severe hypoglycaemia within the last six months or during run-in
6. Symptomatic hypoglycaemia within the last month
7. Currently under consideration to commence insulin
8. Severe heart failure (NYHA class 4)
9. Current or planned renal replacement therapy
10. Unwilling to complete regular follow-up assessments
11. Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years
12. Type 1 or other type of diabetes (e.g. MODY)
13. History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
14. Currently breastfeeding or pregnant, or planning a pregnancy
15. Any serious illness which is likely to limit survival or active participation for at least 5 years
16. Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes
17. For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial
18. Non-adherence to run-in treatment (i.e. reports taking the run-in tablets ‘Never’ or ‘Only occasionally’
19. Their doctor does not wish them to be randomised

Study & Design

• Study Type: Interventional
• Study Design: Not specified