Type 2 diabetes and chronic kidney disease Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus and Chronic kidney disease, unspecified
Conditions
Interventions
Glucophage® SR versus placebo
This will be a multi-centre study. First centre for the study will be: Diabetes centre, Glangwili Hospital, Carmarthen. The second centre will be Diabete
Sponsors
West Wales Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Male or female 3. Patients with Type 2 diabetes 4. Suboptimal glycaemic control {HbA1c = 7.5% (IFCC equivalent = 58mmol/mol)} at the screening visit 5. Chronic kidney disease with Estimated Glomerular Filtration Rate (eGFR) = 30mL/minute/1.73m2 to = 45mL/minute/1.73m2 at the screening visit 6. Stable renal function (eGFR) in the last 3 months 7. Willing and able to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Previous myocardial infarction (MI) (in last 6 months) 2. Previous history of Congestive Cardiac Failure New York Heart Association (NYHA) class III or IV 3. Previous history of Chronic obstructive pulmonary disease (COPD) 4. Chronic kidney disease with eGFR 3fold at baseline) 6. Hypoglycaemia symptoms unawareness 7. History of hypoglycemic episodes requiring 3rd party assistance for reversal in last 12 months 8. Uncontrolled Hypertension (BP > 180/100mmHg) 9. Pregnant or likelihood of pregnancy during the study 10. Females who are breastfeeding 11. Proliferative Diabetic retinopathy and/or laser treatment in last 6 months 12. History of Diabetic ketoacidosis, lactic acidosis and gasteroparesis 13. Current treatment with metformin/Glucophage® SR 14. Treatment with metformin/Glucophage® SR in last 3 months prior to screening visit 15. History of irritable bowel syndrome 16. Previous intolerance to metformin or Glucophage® SR 17. Patients currently on dipeptidyl peptidase IV (DPPIV) inhibitors and Glucagon-Like Peptide (GLP) analogues 18. History of significant (more than one stone) weight loss in last 6 months 19. History of allergic or hypersensitivity reaction to metformin, Glucophage® SR or any insulin 20. Patients unable to tolerate minimum 1000mg daily divided dose of Glucophage® SR 21. Any other condition excluded in Summary of Product Characteristics (SPC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in eGFR from baseline 2. Incidence of lactic acidosis and tolerability (measured by number of patients completed the study) in the Glucophage® SR group of the study compared to placebo | — |
Countries
United Kingdom
Outcome results
None listed