Study of effects of Glucophage SR (a slow relaese metformin) tablet in patients with type-2 (adult onset) Diabetes and mild kidney dysfunction.
- Conditions
- Type-2 Diabetes with chronic kidney disease (eGFR 30 to 45)MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-004245-41-GB
- Lead Sponsor
- Hywel Dda Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Age > 18 years. Male or Female. In addition, patients should fulfill all the following criteria at the randomization visit:
1.Patients with Type – 2 Diabetes.
2.Suboptimal glycaemic control {HbA1c = 7.5% (IFCC equivalent = 58mmol/mol)} at the screening visit.
3.Chronic kidney disease with eGFR = 30mL/minute/1.73m2 to = 45mL/minute/1.73m2 (calculated by MDRD equation) at the screening visit.
4.Stable renal function (eGFR) in the last three months.
5.Willing and able to comply with the study protocol.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1.Previous H/O: M.I. (in last 6 months),
2.Previous history of Congestive Cardiac Failure (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 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 breast feeding.
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 DPPIV inhibitors and 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.Excessive alcohol intake where precipitation of lactic acidosis is suspected.
22.Any other condition excluded in Summary of Product Characteristics (SPC).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.;Secondary Objective: The secondary objectives in this study are: to evaluate change in eGFR from baseline, incidence of lactic acidosis and tolerability (measured by number patients completed the study) in the Glucophage® SR group of the study; compared to placebo.;Primary end point(s): 1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.;Timepoint(s) of evaluation of this end point: The primary outcome will be evaluated at the end of the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary objectives in this study are: to evaluate change in eGFR from baseline, 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.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated at the end of the study.