UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009516
Receipt No. R000011179
Scientific Title Efficacy of voglibose added to alogliptin in Japanese patients with diabetes mellitus
Date of disclosure of the study information 2012/12/31
Last modified on 2014/03/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of voglibose added to alogliptin in Japanese patients with diabetes mellitus
Acronym Efficacy of voglibose added to alogliptin in diabetic patients
Scientific Title Efficacy of voglibose added to alogliptin in Japanese patients with diabetes mellitus
Scientific Title:Acronym Efficacy of voglibose added to alogliptin in diabetic patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate glucose-lowering effect of voglobose added to alogliptin in Japanese patients with type 2 diabetes mellitus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, 1,5-AG, glycoalbumin
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.6 mg per day of voglibose with alogliptin
Interventions/Control_2 0.2 mg per day of voglibose with alogliptin
Interventions/Control_3 alogliptin
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese patients who are treated with alogliptin for type 2 diabetes mellitus
Key exclusion criteria contraindication of voglibose
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Shiraiwa
Organization Shiraiwa Medical Clinic
Division name Shiraiwa Medical Clinic
Zip code
Address Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shiraiwa Medical Clinic
Division name Shiraiwa Medical Clinic
Zip code
Address
TEL 07-2971-1221
Homepage URL
Email

Sponsor
Institute Shiraiwa Medical Clinic
Institute
Department

Funding Source
Organization Shiraiwa Medical Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Metabolic Medicine, Osaka University Graduate School of Medicine
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
2012 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results 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
2012 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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
2012 Year 12 Month 10 Day
Last modified on
2014 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011179

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.