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

Renal Insufficiency, Chronic Clinical Trial

— METXR/CKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895750
• Other study ID #: PI2016_843_0008
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2017
• Est. completion date: October 10, 2022

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 10, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Metformin
Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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