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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029197
Receipt No. R000033252
Scientific Title The effect of additional administration of empagliflozin on patients with linagliptin on renal function
Date of disclosure of the study information 2017/09/19
Last modified on 2017/09/19

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Basic information
Public title The effect of additional administration of empagliflozin on patients with linagliptin on renal function
Acronym The effect of additional administration of empagliflozin on patients with linagliptin on renal function
Scientific Title The effect of additional administration of empagliflozin on patients with linagliptin on renal function
Scientific Title:Acronym The effect of additional administration of empagliflozin on patients with linagliptin on renal function
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We study about efficacy to the renal function of empagliflozin which is added to linaigliptin in clinical use.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Urine albumin creatinine ratio, urin L-FABP.
Key secondary outcomes Glycoalbumin, HbA1c, bodyweight, serum insurin, C-peptide, glucagon, eGFR.
Blood glucose transition (standard deviation and MAGE), and average blood glucose level by a Free Style Libre.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are equipped with a Free Style Libre for 2 weeks from the start of study.
4 weeks after the start of study, patients are randomized to two groups.
Group A: empagliflozin 10mg is added and administration is continued for 12 weeks, and 8 weeks after empagliflozin administration, Free Style Libre Pro is worn for 2 weeks.
At the start of study and 4th week, 12th week, 16th week, we measure these following values on an empty stomach early in the morning, urine albumin creatinine ratio(mg/gCr), urin L-FABP, body weight, BMI, systolic blood pressure, diastolic blood pressure, HbA1c, glycoalbmin, serum AST, ALT, gamma-GTP, BUN, creatinine, UA, eGFR, LDL-C, HDL-C, TG, glucose level, insulin, C-peptide, glucagon.
Interventions/Control_2 Group B: glimepiride 1mg is added and administration is continued for 12 weeks, and 8 weeks after glimepiride administration, Free Style Libre Pro is worn for 2 weeks.
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
15 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Out-patients with type 2 diabetes whose HbA1c are more than 6.5% and less than 15% and who have no changes of diabetic treatment (e.g. diet therapy, exercise cure, medication) within the past 8 weeks and who have been treated with linagliptin 5 mg and without SGLT2 inhibitors and sulfonyulureas.
Key exclusion criteria 1. Patients who have renal dysfunction (eGFR is less than 30ml/min/1.73m2)
2. Pregnant women
3. Patients judged by the doctor to be ineligible
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tosaki
Organization TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name Diabetes and Endocrinology
Zip code
Address 2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL 052-800-2333
Email nrd49075@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tosaki
Organization TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name Diabetes and Endocrinology
Zip code
Address Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL 052-800-2333
Homepage URL
Email nrd49075@nifty.com

Sponsor
Institute TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department

Funding Source
Organization TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
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 医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 19 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 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
2017 Year 09 Month 19 Day
Last modified on
2017 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033252

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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