UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045375
Receipt number R000051813
Scientific Title Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)
Date of disclosure of the study information 2021/09/07
Last modified on 2021/12/20 11:57:17

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Basic information

Public title

Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)

Acronym

Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)

Scientific Title

Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)

Scientific Title:Acronym

Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to investigate the effect on the physiological and psychosomatic dysfunctions as well as metabolic dysfunctions by the combination therapy with DPP4 inhibitor and SGLT2 inhibitor for the patients with type 2 diabetes mellitus

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes of grip strength

Key secondary outcomes

Changes of body weight, HbA1c,blood glucose, blood pressure, circumstance length,GDS15 score,evaluation of psychosomatic activities in IPAQ-SF


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

The participants administrating 10 mg/day of empagliflozin or 5 mg/day of linagliptin are followed by empagliflozin/linagliptin combination tablet administration orally.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with glycated haemoglobin (HbA1c) levels higher than 7.0% (National Glycohemoglobin Standardization Program, NGSP) [52 mmol/mol (International Federation of Clinical Chemistry and Laboratory Medicine, IFCC)], and medicated stable with linagliptin or empagliflozin for at least 3 months were included.

Key exclusion criteria

Patients with urinary tract infection such as pyelonephritis or with impaired renal function (eGFR [estimated Glomerular filtration rate] less than 30 ml/min/1.73 m2) were excluded

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Ayako
Middle name
Last name Nagayama

Organization

Kurume University School of Medicine

Division name

Division of Endocrinology and Metabolism, Department of Internal Medicine

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

TEL

0942-31-7563

Email

nagayama_ayako@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name Ayako
Middle name
Last name Nagayama

Organization

Kurume University School of Medicine

Division name

Division of Endocrinology and Metabolism, Department of Internal Medicine

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

TEL

0942-31-7563

Homepage URL


Email

nagayama_ayako@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University School of Medicine
Division of Endocrinology and Metabolism, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

KURUME Medical Study Group of Internal Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Kurume University School of Medicine

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

Tel

0942-65-3749

Email

i_rinri@kurume-u.ac.jp


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

久留米大学病院(福岡県)、いのくち医院(福岡県)、本間内科循環器内科(福岡県)、稲田内科クリニック(福岡県)、宮崎内科循環器内科(福岡県)、安達医院(福岡県)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 07 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

39

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

No longer recruiting

Date of protocol fixation

2019 Year 06 Month 10 Day

Date of IRB

2019 Year 06 Month 10 Day

Anticipated trial start date

2019 Year 09 Month 01 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 04 Day

Last modified on

2021 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051813


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name