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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02895750
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: Metformin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Glucophage




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895750


Contacts
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Contact: Jean-Daniel LALAU, MD, PhD +33 3 22 45 58 95 lalau.jean-daniel@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, France, 80054
Contact: Jean-Daniel LALAU, MD, PhD    +33 3 22 45 58 95    lalau.jean-daniel@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Jean-Daniel LALAU, MD, PhD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02895750    
Other Study ID Numbers: PI2016_843_0008
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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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
Keywords provided by Centre Hospitalier Universitaire, Amiens:
diabetes type 2
Metformin
chronic kidney disease
CKD
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs