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

May 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
week 0, 2, 4, 6, 8, 10 and 12
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.
week 0, 2, 4, 6, 8, 10 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Jean-Daniel LALAU, MD, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2017

Primary Completion (Actual)

January 8, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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