Type 2 diabetes MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Lyxumia
Product Name: Lixisenatide (Lyxumia)
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: Lixisenatide
CAS Number: 320367-13-3
Other descriptive nam
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if treatment with Lixisenatide for 24 weeks reduces Ao-PWV in T2DM with DN. ;Secondary Objective: To evaluate if treatment with Lixisenatide reduces albumin excretion rate (AER), central aortic pressure, augmentation index, sodium balance, ANP, post prandial sodium, brachial artery pressure and other secondary exploratory objectives.;Primary end point(s): The primary end point will be change from baseline in Ao-PWV. The primary end point is change in Ao-PWV following 24 weeks with Lixisenatide as compared to 24 weeks of placebo treatment.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory secondary endpoints include changes in: - albumin excretion rate (AER), - central aortic pressure, - augmentation index, - sodium balance, - atrial natriuretic peptide (ANP), - post prandial sodium (at 2hrs and area under curve), - brachial artery pressure - panel of vascular and inflammatory markers [which will include VCAM-1, ICAM-1, MMP 2 and 9, serum elastase activity, high sensitive CRP] - AGE (known to be associated with arterial stiffness and albuminuria and potentially affected by GLP-1 agonists). - Samples will also be collected and for future analyses of cardio-renal and metabolic markers. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
United Kingdom
Contacts
Public ContactJanaka Karalliedde
King's College London
Outcome results
None listed