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OpenTrials
Completed

NCT Number: NCT02895750

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

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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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Amiens Picardie

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: Glucophage

Primary outcomes

  1. Efficacy of once daily Metformin XR on 24-h blood glucose control

    Time frame: 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 outcomes

  1. Tolerability of Metformin XR in mild to moderate (CKD)

    Time frame: 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)

  2. Tolerability of Metformin XR in mild to moderate (CKD) 2

    Time frame: week 0, 2, 4, 6, 8, 10 and 12

    blood lactate levels will be measured at the end of each therapeutic block.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: METXR/CKD

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 12, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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