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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal to mild renal impairment | Experimental | (12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN |
|
| mild to moderate renal impairment | Experimental | (12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN |
|
| moderate to severe renal impairment | Experimental | (12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Daniel LALAU, MD, PhD | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Amiens | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34545662 | Result | Lalau JD, Bennis Y, Al-Salameh A, Hurtel-Lemaire AS, Fendri S. Pharmacodynamics and pharmacokinetics of extended-release metformin in patients with type 2 diabetes and chronic kidney disease stage 3B. Diabetes Obes Metab. 2022 Jan;24(1):166-170. doi: 10.1111/dom.14554. Epub 2021 Oct 4. No abstract available. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
blood lactate levels will be measured at the end of each therapeutic block. |
| week 0, 2, 4, 6, 8, 10 and 12 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |