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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026442
Receipt No. R000030380
Scientific Title Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2017/03/07
Last modified on 2017/03/07

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Basic information
Public title Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Acronym Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Scientific Title Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Scientific Title:Acronym Effects of concomitant administration of DPP-4 and SGLT2 inhibitors in Japanese patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 To evaluate effects of concomitant administration of DPP-4 and SGLT2 inhibitors on BMI, glycemic control, plasma lipids, and hepatic function in type 2 diabetic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body mass index, HbA1c, plsma total cholesterol, HDL and LDL cholesterol, triglyceride, AST, ALT, and gamma-GTP levels at 6 months after the start of drug treatment
Key secondary outcomes Plasma uric acid level at 6 months after the start of drug treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 Administration of SGLT2 inhibitor (luseogliflozin 2.5 mg q.d., dapagliflozin 5 mg q.d., tofogliflozin 20 mg q.d., empagliflozin 10 mg q.d., or canagliflozin 100 mg q.d.) for 6 months
Interventions/Control_2 Concomitant administration of SGLT2 inhibitor and DPP-4 inhibitor (sitagliptin 50 mg q.d., vildagliptin 50 mg b.i.d., alogliptin 25 mg q.d., anagliptin 100 mg b.i.d., or linagliptin 5 mg q.d.) for 6 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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria Having severe nephropathy.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Kusunoki
Organization Nagoya University
Division name Research Center of Health, Physical Fitness and Sports
Zip code
Address Furo-cho, Chikusa-ku, Nagoya
TEL 052-789-3946
Email info@tonyo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Kusunoki
Organization Nagoya University
Division name Research Center of Health, Physical Fitness and Sports
Zip code
Address Furo-cho, Chikusa-ku, Nagoya
TEL 052-789-3946
Homepage URL
Email info@tonyo.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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 医療法人社団織田会あきしまクリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 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
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 02 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 02 Day
Last follow-up date
2016 Year 10 Month 27 Day
Date of closure to data entry
2016 Year 11 Month 04 Day
Date trial data considered complete
2016 Year 11 Month 29 Day
Date analysis concluded
2016 Year 12 Month 11 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 07 Day
Last modified on
2017 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030380

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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