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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019867
Receipt No. R000022953
Scientific Title Efficacy of Sitagliptine on Bone and Mineral Metabolism:S-BMM study
Date of disclosure of the study information 2015/11/20
Last modified on 2015/11/20

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Basic information
Public title Efficacy of Sitagliptine on Bone and Mineral Metabolism:S-BMM study
Acronym effects of sitagliptin on bone
Scientific Title Efficacy of Sitagliptine on Bone and Mineral Metabolism:S-BMM study
Scientific Title:Acronym effects of sitagliptin on bone
Region
Japan

Condition
Condition Type2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to determine the effect of sitagliptin on microalbuminuria in patients with type 2 diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome was changes in BAP at 6 months.
Key secondary outcomes

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 sitagliptin 50 mg
Interventions/Control_2 other oral glucose-lowering agents
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
80 years-old >
Gender Male and Female
Key inclusion criteria The study subjects were patients with type 2 diabetes mellitus whose hemoglobin A1c (HbA1c) was lower than 8.4% (according to the National Glycohaemoglobin Standardisation Programme [NGSP]) despite treatment with pioglitazone (15-30 mg/day) for at least 6 months, aged <80 years, who received treatment at the Outpatient Department of the University of Occupational and Environmental Health Hospital or its affiliated hospitals.
Key exclusion criteria Patients with a history of ketoacidosis, patients with type 1 diabetes, patients with nephropathy (serum creatinine: males >1.5 mg/dL females >1.3 mg/dL), patients treated with insulin, and women who were possibly pregnant were excluded from the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Mori
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Homepage URL
Email morihiro@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization MSD
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
2015 Year 11 Month 20 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
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 20 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
2015 Year 11 Month 20 Day
Last modified on
2015 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022953

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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