UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014738 |
|---|---|
| Receipt number | R000017134 |
| Scientific Title | A randomized and comparative study of ipragliflozin and sitagliptin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2018/02/13 13:17:42 |
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Basic information
Public title
A randomized and comparative study of ipragliflozin and sitagliptin in patients with type 2 diabetes
Acronym
A randomized and comparative study of ipragliflozin and sitagliptin in patients with type 2 diabetes
Scientific Title
A randomized and comparative study of ipragliflozin and sitagliptin in patients with type 2 diabetes
Scientific Title:Acronym
A randomized and comparative study of ipragliflozin and sitagliptin in 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 compare the efficacy and safety between a novel oral hypoglycemic SGLT-2 inhibitor ipragliflozin and a usual DPP-4 inhibitor sitagliptin in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients for whom HbA1c decreases 0.5% or more and not increase in weight at 12 weeks after initiation
Key secondary outcomes
Change and percent change in following items from baseline to 12 weeks
1) Serum insulin (immunoreactive insulin)
2) HOMA-IR
3) HOMA-beta
4) Serum lipids
5) LPL (quantitative determination)
6) FFA (free fatty acids)
7) FABP (fatty acid binding protein)
8) P/I ratio (proinsulin/insulin ratio)
9) Serum glucagon
10) Serum ketone body
11) Body composition
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
Orally administration of 50 mg sitagliptin once a day, pre or post breakfast for 12 weeks
Interventions/Control_2
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged from 20 to 75 years at providing consent
2) HbA1c >= 6.5%
3) BMI >= 23 kg/m2
4) Provide written informed consent
Key exclusion criteria
1) Type 1 diabetes
2) Is receiving DPP-4 inhibitor, SGLT-2 inhibitor at providing consent
3) Is receiving insulin therapy at providing consent
4) Poorly controlled patients with metabolic acidosis, etc
5) Has history of severe ketosis, diabetic coma, or precoma
6) With severe infection, pre or post surgery, and serious trauma
7) Is pregnant or possibility of pregnant
8) With thyroid disorder
9) With autoimmune disease
10) With moderate or severe hepatic disorder or renal dysfunction
11) Has history of hypersensitivity to ipragliflozin, sitagliptin, any other excipient, or SGLT-2 inhibitor
12) Considered as inadequate by the investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUYA TSURUTANI |
Organization
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Division name
Endocrinology and Diabetes Center
Zip code
Address
3211 Kozukue-cho, Kohoku-ku, Yokohama, Japan
TEL
045-474-8111
yuyatsurutani@yokohamah.johas.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUYA TSURUTANI |
Organization
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Division name
Endocrinology and Diabetes Center
Zip code
Address
3211 Kozukue-cho, Kohoku-ku, Yokohama, Japan
TEL
045-474-8111
Homepage URL
yuyatsurutani@yokohamah.johas.go.jp
Sponsor or person
Institute
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Physical Checkup Depertment, Yokohama Rosai Hospital
2) Matsuo Naika Clinic
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
独立行政法人労働者健康安全機構 横浜労災病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 04 | 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
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017134
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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