EADER: Liraglutide Effect and Action in Diabetes Evaluation of cardiovascular outcome Results;A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events.

Phase 3

Completed

• Conditions: 10018424; Diabetes Mellitus type 2; non insulin dependent diabetes

• Registration Number: NL-OMON34550
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 175

Inclusion Criteria

• Men or women with type 2 diabetes
• Age >= 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral
vascular disease or chronic renal failure or chronic heart failure OR age >= 60 years at
screening and other specified risk factors of vascular disease
• HbA1c >= 7.0% at screening

Exclusion Criteria

1.Type 1 diabetes
2. Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any
(dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening
3.Use of insulin other than human neutral protamine hagedorn (NPH) insulin or long-acting
insulin analogue within 3 months prior to screening. Short-term use of other insulin during this
period in connection with intercurrent illness is allowed at Investigator*s discretion
4.Acute decompensation of glycaemic control requiring immediate intensification of treatment to
prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months
5.An acute coronary or cerebrovascular event in the previous 14 days
6. Current continuous renal replacement therapy
7.End-stage liver disease
8.Chronic heart failure NYHA IV
9.A prior solid organ transplant or awaiting solid organ transplant
10.Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
medullary thyroid carcinoma (FMTC)
11.Personal history of non-familial medullary thyroid carcinoma
12. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the
previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen*s
disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are
allowed to enter the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>The primary objective will be addressed using the following primary endpoint:<br /><br>Time from randomisation to first occurrence of cardiovascular death, non-fatal<br /><br>myocardial<br /><br>infarction, or non-fatal stroke (a composite cardiovascular outcome)</p><br>