Study of Glucophage® SR iin patients with type 2 diabetes and moderate Kidney dysfunctio

Phase 2

Completed

• Conditions: Type 2 diabetes and chronic kidney disease; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus and Chronic kidney disease, unspecified

• Registration Number: ISRCTN70770260
• Lead Sponsor: West Wales Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-07
• Study Completion: 2014-12-31
• Last Update Posted: 26 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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 < 30mL/minute/1.73m2
5. Abnormal alanine aminotransferase (ALT) (> 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change in eGFR from baseline<br> 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<br>