UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006185 |
|---|---|
| Receipt number | R000007149 |
| Scientific Title | Observation study to assess the effect of Alogliptin on bone metabolism in type 2 diabetic patient |
| Date of disclosure of the study information | 2011/08/17 |
| Last modified on | 2013/02/18 10:14:15 |
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Basic information
Public title
Observation study to assess the effect of Alogliptin on bone metabolism in type 2 diabetic patient
Acronym
Observation study to assess the effect of Alogliptin on bone metabolism in type 2 diabetic patient
Scientific Title
Observation study to assess the effect of Alogliptin on bone metabolism in type 2 diabetic patient
Scientific Title:Acronym
Observation study to assess the effect of Alogliptin on bone metabolism in type 2 diabetic patient
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 study the effect of Alogliptin, Dipeptidyl Peptidase-4 inhibitor, on bone metabolism in type 2 diabetic patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of bone mineral density and biochemical marker of bone metabolic turnover 4 months after administration of Alogliptin
Key secondary outcomes
Change of physical findings, glucose metabolism, lipid metabolism, liver function and bone metabolism-related factors 4 months after administration of Alogliptin.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patient whose HbA1c(JDS) is more than or equal to 5.8 %.
(HbA1c value at a registration differs from preceding test is less than 2.0%.)
Patient indicated necessity of Alogliptin administration.
Patient who is competent to understand the aim of this study and agree on it.
Key exclusion criteria
Patient taking medication of bone-building drug or medication that may highly likely influence bone turnover.
Secondary osteoporosis.
Patient taking another kind of DPP-4 inhibitor.
Insulin-treated diabetic patient.
Patient with a history of heart failure, liver dysfunction, severe liver disorder, severe kidney disorder.
Patient during acute stage of bone fracture or therapy of malignancy.
Patient with endocrine disorder, gastrointestinal disease or malignancy that may highly influence bone turnover.
Drug abuser.
Heavy user of alcohol.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Tsunekawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL
+81-52-744-2142
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Tsunekawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL
+81-52-744-2142
Homepage URL
Sponsor or person
Institute
Department of Endocrinology and Diabetes
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Diabetes
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
名古屋大学病院（Nagoya University Hospital)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 17 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To study the effect of Dipeptidyl Peptidase-4 inhibitor, Alogliptin, on bone metabolism in type 2 diabetic patients, we will examine change of bone mineral density , biochemical marker of bone metabolic turnover and bone metabolism-related factors 4 months after administration of Alogliptin
Management information
Registered date
| 2011 | Year | 08 | Month | 17 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007149
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
