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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021658
Receipt No. R000024973
Scientific Title Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Date of disclosure of the study information 2016/05/01
Last modified on 2018/11/13

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Basic information
Public title Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Acronym Comparison of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Scientific Title Investigation on efficacy and safety of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Scientific Title:Acronym Comparison of order of SGLT-2 inhibitor and DPP-4 inhibitor administration
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety between two groups: one of which is initially administered an SGLT-2 inhibitor, luseogliflozin, followed by a DPP-4 inhibitor, sitagliptin, and the other which is initially administered a sitagliptin followed by luseogliflozin, in Japanese patients with type 2 diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change from baseline in HbA1c
Key secondary outcomes Blood glucose (fasting), IRI, CPR, Glucagon, Leptin, diponectin, TG, TC, LDL-C, HDL-C, ALT (GPT), AST (GOT), GGT, Uric acid, Creatinine, L-FABP, Urine microalbumin, Blood pressure, Body weight, Questionnaire (patient satisfaction, etc.)

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 After luseogliflozin 2.5 mg monotherapy for 3 months, sitagliptin 50 mg is concomitantly administered for 3 months
Interventions/Control_2 After sitagliptin 50 mg monotherapy for 3 months, luseogliflozin 2.5 mg is concomitantly administered for 3 months
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 "1) Type 2 diabetes mellitus patients on diet and exercise therapy with inadequate blood glucose control
2) More than 20 years of age at the time of informed consent acquisition
3) Both females and males
4) Patients whose HbA1c (NGSP values) is more than 6.5%
5) Patients who received explanation of the study by using an informed consent form and gave written consent on study participation
"
Key exclusion criteria "1) Patients with type 1 diabetes mellitus
2) Patients who had severe ketosis, diabetic coma, or precoma within 6 months
3) Patients with severe infection, perioperative patients, patients with severe trauma
4) Patients hypersensitive to ingredients of the drug used or its excipient
5) Patients with severe renal dysfunction (eGFR < 30 ml/min/1.73 m2) or terminal renal failure patients undergoing dialysis
6) Patients with severe hepatic dysfunction
7) Patients who are pregnant or breast-feeding
8) Patients considered inappropriate to participate in the study by the principal (sub-) investigator
"
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Takihata
Organization Miura Central Clinic
Division name internal medicine
Zip code
Address 1738-1 Kamimiyada, Minamishitauramachi Miura, Kanagawa, Japan
TEL 046-888-5010
Email takihata-hki@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Takihata
Organization Miura Central Clinic
Division name internal medicine
Zip code
Address 1738-1 Kamimiyada, Minamishitauramachi Miura, Kanagawa, Japan
TEL 046-888-5010
Homepage URL
Email takihata-hki@umin.ac.jp

Sponsor
Institute Miura Central Clinic
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical Co. ,Ltd.
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 05 Month 01 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
2015 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 28 Day
Last modified on
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024973

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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