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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023959
Receipt No. R000027582
Scientific Title Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Date of disclosure of the study information 2016/09/06
Last modified on 2017/12/27

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Basic information
Public title Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Acronym Effect of canagliflozin on microalbuminuria in type 2 diabetic patients
Scientific Title Effect of canagliflozin on urinary albumin excretion in type 2 diabetic patients with microalbuminuria (pilot study)
Scientific Title:Acronym Effect of canagliflozin on microalbuminuria in type 2 diabetic patients
Region
Japan

Condition
Condition Type 2 diabetic patients with microalbuminuria
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of canagliflozin on diabetic nephropathy in type 2 diabetic patients with microalbuminuria by evaluating 24-hr urine albumin excretion. In addition, several markers of renal impairment are exploratory studied.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Percent change in the 24-hour urine albumin excretion level (mg/day) from baseline to 12 weeks.
Key secondary outcomes Changes or percent changes in the following markers from baseline to 12 weeks.
1) HbA1c, fasting blood glucose
2) Body weight, BMI
3) eGFR (by serum creatinine, serum cystatin C), creatinine clearance
4) Urinary albumin (first morning voids, creatinine ratio)
5) Tubular and glomerular damage marker: Urinary type IV collagen, urinary transferrin, urinary NAG, urinary L-FABP, urinary B2 microglobulin, urinary NGAL, urinary KIM-1, serum TNFR1, serum TNFR2
6) Inflammatory marker: Serum IL-18, Serum high-sensitivity C-reactive protein
7) Oxidative stress marker: Urinary 8-OHdG
8) Blood pressure, serum uric acid, urinary aldosterone, serum aldosterone, plasma renin activity
9) Hematocrit
10) Serum erythropoietin
11) Absolute change in the 24-hour urine albumin (mg/day)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Canagliflozin 100mg, once daily, before or after breakfast, oral administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Type 2 diabetes
2. Age >=20, 75> years on the date of submission of informed consent
3. Submission of written informed consent for participation in the study
The following criteria are confirmed by data available on the visit for eligibility confirmation.
4. HbA1c=<10%(NGSP)
In case of patients with age >=65, 75> years administered with SU and/or glinide, 6.5%=<HbA1c=<10%(NGSP)
5. Blood pressure: <140/90mmHg
6. Urinary albumin: 30.0-299.9mg/g.Cr (first morning voids)
7. eGFR>=45mL/min/1.73m2
Key exclusion criteria 1. Type 1 diabetes
2. The following drugs are administered (the date of submission of informed consent)SGLT2 inhibitor Insulin GLP-1receptor agonist
3. History of hypersensitivity to canagliflozin
4. Has severe ketosis, diabetic coma or semi-coma
5. Has severe infection, trauma or perioperative
6. Possible or definitive pregnant women or nursing mother
7. Has malignant tumor or suspicious for
8. Has urinary tract infection
9. Has NYHA class IV heart failure
10. Has severe anemia
11. Considered not eligible for the study by principal or other investigators due to other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Osonoi
Organization Nakakinen clinic Medical Corporation Kensei-kai
Division name Director
Zip code
Address 745-5, Nakadai, Naka, Ibaraki
TEL 029-353-2800
Email k-ofuchi@kensei-kai.com

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Ofuchi
Organization Nakakinen clinic Medical Corporation Kensei-kai
Division name department of clinical research
Zip code
Address 745-5, Nakadai, Naka, Ibaraki
TEL 029-353-2800
Homepage URL
Email k-ofuchi@kensei-kai.com

Sponsor
Institute Nakakinen clinic Medical Corporation Kensei-kai
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 06 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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