ixisenatide Arterial Stiffness Trial

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

?Written informed consent
?T2DM patients aged =40 years with DN defined as a history of an elevated AER [albumin:creatinine ratio (ACR) =2.5mg/mmol in men and =3mg/mmol in women or AER =20mcg/min] or positive urine dipstick result for proteinuria or urine protein creatinine ratios (PCR)>15 mg/mmol or clinical evidence of diabetic nephropathy] in the absence of other causes of renal damage or urinary tract infections,
?estimated glomerular filtration rate (eGFR)* =30 ml/min;
?On anti-hypertensive therapy with renin angiotensin system (RAS) inhibitor at a stable dose for at least 1 month prior to randomisation
?HbA1c =6.5% on anti-diabetic medications
?Body mass index =30 kg/m2 or =27 kg/m2 (people from black, Asian and other minority ethnic groups and for whom insulin therapy would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities)
* by Modification of Diet in Renal Disease (MDRD) Study equation [186 x (Creat / 88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black) ]

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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

?Patients with eGFR<30 ml/min;
?Patients with recent (within 1 year) history of CVD event;
?Patients with uncontrolled hypertension defined as systolic BP and diastolic BP greater than 180 and 110mmHg respectively;
?Pregnancy or lactation;
?Females of child bearing potential or males able to father a child who do not agree to use suitable methods of contraception (as specified in section 4.7 of the Protocol)
?Patients with non diabetic renal disease;
?Patients expected to receive an increase in the dose of RAS inhibitors during the course of study;
?History of pancreatitis;
?Active gastrointestinal (GI) or biliary disease;
?Planned major GI surgery that can/could affect upper GI function;
?History or family history of thyroid cancer or multiple endocrine neoplasia 2;
?Known allergy/intolerance to GLP-1 receptor agonist treatment, metacresol or any of the IMP or placebo components.
?Subjects involved in current research or have recently (within 30 days) been involved in any research involving an IMP prior to recruitment.
?Subjects with insufficient understanding of the Trial or unable to comply with study requirements
?Subjects on basal insulin and a sulphonylurea at randomisation visit.
?Patients already on a GLP-1 receptor agonist therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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