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

Phase 2

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Metformin

• Registration Number: NCT02895750
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Study Start: 2017-08-30
• Primary Completion: 2022-01-08
• Study Completion: 2022-10-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild to moderate renal impairment	Metformin	(12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN
normal to mild renal impairment	Metformin	(12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN
moderate to severe renal impairment	Metformin	(12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France