UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029197
Receipt number 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 2020/03/22 20:56:19

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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 Takahiro
Middle name
Last name Tosaki

Organization

TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology

Division name

Diabetes and Endocrinology

Zip code

4680009

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 Takahiro
Middle name
Last name Tosaki

Organization

TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology

Division name

Diabetes and Endocrinology

Zip code

4680009

Address

2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan

TEL

052-800-2333

Homepage URL


Email

nrd49075@nifty.com


Sponsor or person

Institute

TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology

Institute

Department

Personal name



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

Ethic commitee of TDE Healthcare Corporation

Address

2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan

Tel

052-800-2333

Email

nrd49075@nifty.com


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

2020 Year 03 Month 22 Day



Link to view the page

Value
https://center6.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