Efficacity and Safety of Metformin XR in CKD Stage 1 to 3

Study Overview
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Brief Summary
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There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.

Official Title
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Efficacity and Safety of Metformin XR in CKD Stage 1 to 3

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment) Exclusion Criteria: Pregnancy and lactation Hyperlactatemia (> 2.5 mmol/L) No creatinine levels available since 3 months Severe hepatic insufficiency No liver function parameters available Need of investigation with iodized contrast media Hypersensitivity to metformin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normal to mild renal impairment<br>(12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN | Drug: Metformin<br>* Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)<br>* Other names: Glucophage;|
| Experimental: mild to moderate renal impairment<br>(12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN | Drug: Metformin<br>* Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)<br>* Other names: Glucophage;|
| Experimental: moderate to severe renal impairment<br>(12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN | Drug: Metformin<br>* Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)<br>* Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of once daily Metformin XR on 24-h blood glucose control | The blood glucose will be measured continuously throughout the study using continuous glucose monitoring (mean, range and variability in each therapeutic block). | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Metformin XR in mild to moderate (CKD) | Blood creatinine levels will be measured at the end of each therapeutic block. (week 0, 2, 4, 6, 8, 10 and 12) | week 0, 2, 4, 6, 8, 10 and 12 | 
| Tolerability of Metformin XR in mild to moderate (CKD) 2 | blood lactate levels will be measured at the end of each therapeutic block. | week 0, 2, 4, 6, 8, 10 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes type 2, Metformin, chronic kidney disease, CKD