Study of alternative drug to insulin for the treatment of high blood glucose concentration in cardiac surgery patients

Phase 1

• Conditions: Hyperglyceamia during Cardiac Surgery; MedDRA version: 20.0Level: LLTClassification code 10060439Term: Stress induced hyperglycaemiaSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-000043-40-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

•Adult patients, aged 18-80 years (inclusive),
•No known diabetes mellitus, or
•Known diabetes mellitus type 2 on oral glucose lowering medication, diet or total daily insulin dose =0.5 IU/kg
•Scheduled for an elective cardiac surgical procedure.
•Informed consent obtained before any trial-related activities are carried out.
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 174
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Diabetes mellitus type 1
•Emergency surgery
•Receiving oral corticosteroid therapy
•History of pancreatic surgery or acute or chronic pancreatitis
•Personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia23 syndrome type 2 (MEN2)
•Heart failure NYHA class IV
•Serum-creatinine = 133 µmol l-1 for males and = 115 µmol l-1 for females, measured within 6 months before date of surgery.
•Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
•Current treatment with GLP-1 analogues
•Known or suspected allergy to trial products or other drugs in the same class

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified