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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017113
Receipt No. R000019543
Scientific Title Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus
Date of disclosure of the study information 2015/05/26
Last modified on 2018/10/15

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Basic information
Public title Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus
Acronym Comparative study of ipragliflozin versus metformin on adipocytokine levels
Scientific Title Effect of gulcose-lowering agents on adipocytokine levels in patients with diabetes mellitus
Scientific Title:Acronym Comparative study of ipragliflozin versus metformin on adipocytokine levels
Region
Japan

Condition
Condition type 2 diabetic patients with coronary artery disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of ipragliflozin or metformin in combination with DPP4-inhibitors on adipocytokine levels in type 2 diabetic patients with coronary artery disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in adipocytokine
Key secondary outcomes Changes in glucose metabolism
Changes in body weight and abdominal circumference
Changes in laboratory parameters
Assessment of vascular event

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 group A: additive therapy of ipragliflozin 50-100mg once daily to DPP4 inhibitor for 6 months
Interventions/Control_2 Group B: additive therapy of metformin 250-750mg twice daily to DPP4 inhibitor 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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who have a history of following coronary heart diseasese
CABG or PCI was performed more than 6 months before
>= 50% coronary artery stenosis according to the ACC/AHA classification was found by CAG
2) Diabetic patients under treatment of DPP-4 inhibitor more than 3 months
3) Patients who are judged to require the more glucose-lowering therapy
Key exclusion criteria 1) Patients with malignancy
2) Patients with history of hypersensitivity against DPP4 inhibitor, SGLT2 inhibitor, and biguanide drugs
3) patients whose glycemic control is extremely poor (HbA1c >=10%)
4) patients whose glycemic control is very poor (HbA1c >=10%)
5) Pregnant women, women who may be pregnant, and breast-feeding women.
6) Patients with history of renal transplantation, urinary infection, sexually transmission disease, and non-cardiogenic stroke
7) Patients who took diuretics
8) patients whose BMI is lower than 18.5
9) Patients with history of acute coronary syndrome within 6 months
10) Patients judged by the investigator/ sub investigator to be ineligible for some other reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Watarai
Organization Anjo Kosei Hospital
Division name Cardiovascular Center
Zip code
Address 28, Higashi-Hirokute, Anjo, Anjo, Aichi
TEL 0566-75-2111
Email watarai@kosei.anjo.aichi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Uemura
Organization Anjo Kosei Hospital
Division name cardiovascular Center
Zip code
Address 28, Higashi-Hirokute, Anjo, Anjo, Aichi
TEL 0566-75-2111
Homepage URL
Email yusuke0307@hotmail.com

Sponsor
Institute Anjo Kosei Hospital, Cardiovascular Center
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 26 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 15 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 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
2015 Year 04 Month 13 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019543

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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