UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019867 |
|---|---|
| Receipt number | 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 09:37:39 |
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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
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
morihiro@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022953
