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

Primary Purpose

Renal Insufficiency, Chronic

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring diabetes type 2, Metformin, chronic kidney disease, CKD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

normal to mild renal impairment

mild to moderate renal impairment

moderate to severe renal impairment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

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

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

Full Information

NCT ID

NCT02895750

First Posted

July 26, 2016

Last Updated

May 9, 2023

Sponsor

Centre Hospitalier Universitaire, Amiens

1. Study Identification

Unique Protocol Identification Number

NCT02895750

Brief Title

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

Acronym

METXR/CKD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

August 30, 2017 (Actual)

Primary Completion Date

January 8, 2022 (Actual)

Study Completion Date

October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic

Keywords

diabetes type 2, Metformin, chronic kidney disease, CKD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

normal to mild renal impairment

Arm Type

Experimental

Arm Description

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

Arm Title

mild to moderate renal impairment

Arm Type

Experimental

Arm Description

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

Arm Title

moderate to severe renal impairment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

The blood glucose will be measured continuously throughout the study using continuous glucose monitoring (mean, range and variability in each therapeutic block).

Time Frame

week 12

Secondary Outcome Measure Information:

Title

Tolerability of Metformin XR in mild to moderate (CKD)

Description

Blood creatinine levels will be measured at the end of each therapeutic block. (week 0, 2, 4, 6, 8, 10 and 12)

Time Frame

week 0, 2, 4, 6, 8, 10 and 12

Title

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

Description

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

Time Frame

week 0, 2, 4, 6, 8, 10 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Daniel LALAU, MD, PhD

Organizational Affiliation

CHU Amiens

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens Picardie

City

Amiens

ZIP/Postal Code

80054

Country

France

12. IPD Sharing Statement

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

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