Coronary artery disease MedDRA version: 9.1 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery disorders MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Trade Name: Januvia (sitagliptin)
Product Name: Sitagliptin (Januvia, MSD)
Pharmaceutical Form: Coated tablet
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes on treatment with metformin, a sulphonylurea or a thiazolidinedione Known coronary artery disease Good left ventricular function Sinus rhythm 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Type 2 diabetes on treatment with metformin, a sulphonylurea or a thiazolidinedione Known coronary artery disease Good left ventricular function Sinus rhythm 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Type 1 diabetes Treatment with insulin, exenatide, sitagliptin or vildagliptin Renal impairment (creat > 175 micromol/l) Hepatic impairment Poor left ventricular function Atrial fibrillation Permanent pacemaker Significant valvular heart disease or other structural heart disease ;Exclusion criteria: Type 1 diabetes Treatment with insulin, exenatide, sitagliptin or vildagliptin Renal impairment (creat > 175 micromol/l) Hepatic impairment Poor left ventricular function Atrial fibrillation Permanent pacemaker Significant valvular heart disease or other structural heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: An inadequate supply of oxygen to the heart, due to narrowed coronary arteries, may result in impaired contractile performance during exercise. The use of glucose rather than fat as the major energy source may enable the heart to continue pumping normally despite the constrained delivery of oxygen. Glucagon-like peptide-1 (GLP-1) has been shown to promote myocardial glucose use. The breakdown of GLP-1 can be inhibited by sitagliptin (Januvia, MSD) which is licensed for the treatment of type 2 diabetes. We have shown that a single dose of sitagliptin produces an acute improvement in cardiac performance on exercise in patients with coronary disease. This study will assess whether a longer period of treatment with sitagliptin for 4 weeks will produce a chronic improvement in myocardial performance in patients with type 2 diabetes.;Secondary Objective: None;Primary end point(s): The primary outcome measure is the effect of sitagliptin on LV ejection fraction following dobutamine stress.;Main Objective: An inadequate supply of oxygen to the heart, due to narrowed coronary arteries, may result in impaired contractile performance during exercise. The use of glucose rather than fat as the major energy source may enable the heart to continue pumping normally despite the constrained delivery of oxygen. Glucagon-like peptide-1 (GLP-1) has been shown to promote myocardial glucose use. The breakdown of GLP-1 can be inhibited by sitagliptin (Januvia, MSD) which is licensed for the treatment of type 2 diabetes. We have shown that a single dose of sitagliptin produces an acute improvement in cardiac performance on exercise in patients with coronary disease. This study will assess whether a longer period of treatment with sitagliptin for 4 weeks will produce a chronic improvement in myocardial performance in patients with type 2 diabetes.;Secondary Objective: None;Primary end point(s): The primary outcome measure is the effect of sitagliptin on LV ejection fraction f | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed