Efficacity and Safety of Metformin XR in CKD Stage 1 to 3 (METXR/CKD)

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 2

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02895750

PI2016_843_0008

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

normal to mild renal impairment

Experimental group

Description:

(12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN

Treatment:

Drug: Metformin

mild to moderate renal impairment

Experimental group

Description:

(12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN

Treatment:

Drug: Metformin

moderate to severe renal impairment

Experimental group

Description:

(12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN

Treatment:

Drug: Metformin