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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014422
Receipt No. R000016779
Scientific Title Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Date of disclosure of the study information 2014/06/30
Last modified on 2015/07/01

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Basic information
Public title Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Acronym Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Scientific Title Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Scientific Title:Acronym Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factors
Region
Japan

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

Objectives
Narrative objectives1 Comparison between the non-administration group and the administration group of SGLT2 inhibitor
1) Change of s-dense-LDL (sd-LDL), IDL, LDL, VLDL and HDL
2) Change of body weight, blood pressure
3) Change of HOMA-beta, HOMA-IR, hsCRP
4) Change of serum creatinine, cystatin C and urinary albumin
5) Change of HbA1c and GA
6) To evaluate the change of dietary lifestyle (based on dietary habits questionnaire)
7) To evaluate the safety such as dehydration, urinary tract infection and genital infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Improving effects of sd-LDL, IDL, LDL and HDL using by Lipofo-AS
2) TC, TG, HDL-C, LDL-C, LDL/HDL-C rate and non HDL-C
Key secondary outcomes 1) Lowering effects of body weight and blood pressure
2) Improving effects of hsCRP, HOMA-beta and HOMA-R
3) Lowering effects of HbA1c and GA

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks
Interventions/Control_2 Ipragliflozin non-administrated group (Continuation of conventional therapy)
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Aged from 20 to less than 65 years at providing consent
2) Type 2 diabetes patients with BMI >= 24 kg/m2
3) HbA1c (NGSP) was from 7% to less than 10% for 3 months or more, under conventional thrapy (HbA1c >= 7.5% in case of having sulfonylureas and glinides)
Key exclusion criteria 1) With receiving insulin therapy
2) With a history of ischemic heart disease (angina pectoris, myocardial infarction) and ischemic stroke
3) Serum Creatinine >= 1.2 mg/dL
4) Fasting serum triglycerides levels >= 400 mg/dL
5) HbA1c was changed 2% or more within 3 months
6) With unconscious thirst (impossible self-judgement water intake)
7) With contraindication for ipragliflozin
a) History of hypersensitivity to ipragliflozin
b) Severe ketosis, diabetic or precoma
c) Severe infection, pre or post surgery, and severe trauma
8) Considered as inadequate by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Bando
Organization Fukui-ken Saiseikai Hospital
Division name internal
Zip code
Address Funabashi 7-1, Wadanaka-cho, Fukui-city, Fukui, Japan
TEL 0776-23-1111
Email Y-BANDO@fukui.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Bando
Organization Fukui-ken Saiseikai Hospital
Division name internal
Zip code
Address Funabashi 7-1, Wadanaka-cho, Fukui-city, Fukui, Japan
TEL 0776-23-1111
Homepage URL
Email Y-BANDO@fukui.saiseikai.or.jp

Sponsor
Institute Fukui-ken Saiseikai 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
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
2014 Year 06 Month 30 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
2014 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 07 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
2014 Year 06 Month 30 Day
Last modified on
2015 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016779

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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