Overview

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

Status:
Completed

Trial end date:
2016-03-15

Target enrollment:
0

Participant gender:
All

Summary

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Criteria

Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to
50 years at screening and clinical evidence of cardiovascular disease or age above or equal
to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic
drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human
Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed
insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c
above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of
glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or
pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV)
inhibitor within 30 days prior to screening - Treatment with insulin other than basal and
pre-mixed insulin within 90 days prior to screening - except for short-term use in
connection with intercurrent illness - Acute decompensation of glycaemic control requiring
immediate intensification of treatment to prevent acute complications of diabetes (eg
diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis
or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days
prior to randomisation - Currently planned coronary, carotid or peripheral artery
revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV -
Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial
medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma
- Screening calcitonin above or equal to 50 ng/L