UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017113 |
|---|---|
| Receipt number | 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 13:43:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yusuke0307@hotmail.com
Sponsor or person
Institute
Anjo Kosei Hospital, Cardiovascular Center
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.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 |
