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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001111
Receipt No. R000001290
Scientific Title Long-term effects of voglibose on diabetic complication in Japanese patients with type 2 diabetes mellitus: a double-blind, randomized, placebo-controlled clinical trial
Date of disclosure of the study information 2008/04/07
Last modified on 2010/08/27

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Basic information
Public title Long-term effects of voglibose on diabetic complication in Japanese patients with type 2 diabetes mellitus: a double-blind, randomized, placebo-controlled clinical trial
Acronym Long-term effects of voglibose on diabetic complication in Japanese patients with type 2 diabetes mellitus
Scientific Title Long-term effects of voglibose on diabetic complication in Japanese patients with type 2 diabetes mellitus: a double-blind, randomized, placebo-controlled clinical trial
Scientific Title:Acronym Long-term effects of voglibose on diabetic complication in Japanese patients with type 2 diabetes mellitus
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to determine whether suppression of postprandial hyperglycemia during long-term treatment with voglibose prevented the development or progression of diabetic retinopathy or nephropathy in Japanese patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The development or progression of diabetic retinopathy and/or nephropathy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 In addition to their baseline treatment, patients were randomized to receive oral voglibose (0.2 mg three times daily for 8 weeks and then 0.3 mg three times daily for 136 weeks.
Interventions/Control_2 In addition to their baseline treatment, patients were randomized to receive oral matching placebo three times daily for 144 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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1)Absence of diabetic retinopathy, or the presence of simple background retinopathy or mild preproliferative retinopathy
2) Those who are being treated with diet or exercise with or without a sulfonylurea.
3) Fasting blood glucose level of 160 mg/dL or less at the start of the run-in period or 4 weeks after the beginning of the run-in period.
4) Mean urinary albumin-to-creatinine ratio of 300 mg/g or less creatinine at the start of the run-in period or 4 weeks after the beginning of the run-in period.
Key exclusion criteria 1) Those who are not allowed mydriasis due to glaucoma etc.
2) History of photocoagulation
3) Those who are inable to evaluate diabetic retinopathy due to internal ophthalmic surgery, corneal diseases or cataract etc.
4) Those who experienced a cerebrovascular event during the run-in period.
5) Those who experienced a significant ECG abnormality, significant cardiac diseases (myocardial infarction or angina pectoris) or arteriosclerosis obliterans (skin ulcer, gangrene or intermittent claudication) during the run-in period.
Target sample size 550

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Shigeta
Organization Shiga University of Medical Science Hospital
Division name Emeritus Professor
Zip code
Address Setatsukiwacho, Ootsu-Shi,Shiga,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Takeda Pharmaceutical Company Limited
Division name Contact for Clinical Trial Infomation
Zip code
Address
TEL
Homepage URL https://www.takeda.co.jp/contact/form/jp/form/
Email

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2008 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.takeda.com/c-t/report-summaries/article_53.html
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
1999 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2000 Year 03 Month 01 Day
Last follow-up date
2006 Year 11 Month 01 Day
Date of closure to data entry
2007 Year 02 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 04 Day
Last modified on
2010 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001290

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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