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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014738
Receipt No. 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

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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
Email 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
Email yuyatsurutani@yokohamah.johas.go.jp

Sponsor
Institute Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017134

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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