E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Kidney disease in patients with type 2 diabetes. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012687 |
E.1.2 | Term | Diabetic renal disease |
E.1.2 | System Organ Class | 100000004857 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Objective:
The primary objective of this study is to compare the change in pro-inflammatory cytokine monocyte-chemotactic protein 1 (MCP-1) in urine in subjects treated with liraglutide over a 26 week treatment period versus a matched control group who received no liraglutide.
|
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to compare:
1. Changes in serum and urine sCD163
2. Changes in urinary albumin excretion rates
3. Safety
between both subject groups over a 26 week treatment period.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Only patients who meet all of the following inclusion criteria will be eligible for enrolment into this study:
1. Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT)
2. Male or female between 30 – 75 years of age
3. Have a negative pregnancy test at screening (women of child bearing potential only)
4. Body mass index (BMI) of 25kg/m2or greater
5. On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before
inclusion into the study
6. Established microalbuminuria (as defined by two positive urine test results)
7. Estimated glomerular filtration rate (eGFR) 30 ml/min/1.73m2 or greater by Modification of Diet in Renal Disease (MDRD) formula
|
|
E.4 | Principal exclusion criteria |
Patients meeting any of the following exclusion criteria are not eligible
for enrolment into this study:
1. Patients with any cognitive impediment that preclude the patient from giving free and informed consent
2. Patients on dipeptidyl peptidase 4 inhibitors
3. Patients who require insulin therapy who are not using an insulin product with an indication for adding in liraglutide
4. Patients with stage 4-5 renal disease, defined as an eGFR of 29ml/min/1.73m2 or less
5. Patients who have used a GLP-1 agent in the last 6 months
6. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study
7. Previous pancreatitis
8. Hypersensitivity to GLP-1 analogues
9. Proliferative diabetic retinopathy
10. Any other contraindications, as per the SmPC for liraglutide
11. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements
12. Concurrent treatment with an investigational drug or participation in another clinical trial
13. Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the measurement of the change in pro-inflammatory cytokine monocyte-chemotactic protein 1 (MCP-1) in urine over a 26 week treatment period in subjects treated with liraglutide versus a matched control group who received no liraglutide. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints of this study are the measurement of:
1. Changes in serum and urine sCD163
2. Changes in urinary albumin excretion rates
3. Safety as measured by changes from Baseline Visit in physical examination findings, safety laboratory test results, vital signs and adverse events reported
between both subject groups.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard of care, without liraglutide |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |