UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001111 |
|---|---|
| Receipt number | 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 17:16:19 |
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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
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/
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001290
