To compare gliclazide with linagliptin on the frequency of hypoglycaemia among patients with type II diabetes and chronic kidney disease stage 3b and 4.
- Conditions
- Diabetes Mellitus and chronic kidney diseaseTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2015-002309-12-GB
- Lead Sponsor
- Imperial College London, Joint Research Compliance Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1. T2DM of 10 years or more duration
2. Age between 50 yrs and 75 yrs
3. eGFR 15 to 45ml/min/1.73m2
4. HbA1c <8% (<65mmol/mol)
5. Rx Gliclazide (± Metformin)
6. Stable diabetic control (i.e. last 2 months prior to randomisation)
7. Individuals who adequately understand written and verbal English.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. T1DM
2. Currently on insulin, pioglitazone, other dipeptidylpeptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists
3. Immunosuppressive therapy within the previous year
4. Pregnant or lactating women
5. Malignancy or other life threatening illness
6. Inability to give informed consent
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