NCT02895750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4.4 years

First QC Date

July 26, 2016

Last Update Submit

September 16, 2025

Conditions

Renal Insufficiency, Chronic

Keywords

diabetes type 2Metforminchronic kidney diseaseCKD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

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

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

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

Study Arms (3)

normal to mild renal impairment

EXPERIMENTAL

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

Drug: Metformin

mild to moderate renal impairment

EXPERIMENTAL

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

Drug: Metformin

moderate to severe renal impairment

EXPERIMENTAL

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

Drug: Metformin

Interventions

MetforminDRUG

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

Also known as: Glucophage
mild to moderate renal impairmentmoderate to severe renal impairmentnormal to mild renal impairment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, 80054, France

Location

Related Publications (1)

  • Lalau JD, Bennis Y, Al-Salameh A, Hurtel-Lemaire AS, Fendri S. Pharmacodynamics and pharmacokinetics of extended-release metformin in patients with type 2 diabetes and chronic kidney disease stage 3B. Diabetes Obes Metab. 2022 Jan;24(1):166-170. doi: 10.1111/dom.14554. Epub 2021 Oct 4. No abstract available.

    PMID: 34545662RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jean-Daniel LALAU, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

September 12, 2016

Study Start

August 30, 2017

Primary Completion

January 8, 2022

Study Completion

October 10, 2022

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)