UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007759 |
|---|---|
| Receipt number | R000008890 |
| Scientific Title | The investigation of clinical effects of repaglinide in diabetic patients over 65 years old |
| Date of disclosure of the study information | 2012/05/20 |
| Last modified on | 2014/12/05 13:25:50 |
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Basic information
Public title
The investigation of clinical effects of repaglinide in diabetic patients over 65 years old
Acronym
The clinical effects of repaglinide on elderly
Scientific Title
The investigation of clinical effects of repaglinide in diabetic patients over 65 years old
Scientific Title:Acronym
The clinical effects of repaglinide on elderly
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigation of clinical effects and safety of repaglinide on the elderly
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
TC, LDL, HDK, TG, Blood glucose, CRP, ASST, ALT, gGTP
Key secondary outcomes
adverse events
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)a)diavetic patients with diet and exercise therapy over 8 weeks
b)diavetic patients with diet, exercise therapy and arufa GI over 12weeks
2)6.9% <=HbA1c<=9.4%
3)age over 65 years old
4)patients with written informed consent
Key exclusion criteria
1) aptients with severe ketosis:ketotic coma or precoma
2)severe infectious disease
3)liver dysfunction (more than 2.5 times of the upper normal limit in AST and ALT
4)kidney dysfunction: sCR>=2mg/dl
5)heart disease: heart failure (NYHAIII andIV unstable aigina, MI within 12months
6)diabetic complications: proliferative retinopathy or preproliferative retinopathy, severe nueropathy with need of treatment
7) severe and uncontrolable hypertension: systolic BP 180mmHg, or diastolic 110nnHg
8) alcholics: more than 2 large bottles of beer
9) makignancy
10) alergy for glimides and SUs
11) pregnant
12) patients with past prescription of lepagrinide
13) attending doctors decision
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Umegaki |
Organization
Nagoya University Hospital
Division name
Geriatric medicine
Zip code
Address
65 Tsuruma, Showa, Nagoya, Aichi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Hospital
Division name
Geriatric medicine
Zip code
Address
TEL
052-744-2364
Homepage URL
Sponsor or person
Institute
Nagoya University Hospital Department of Geriatric medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital Department of Geriatric 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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | 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 | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Observation has not syarted
Management information
Registered date
| 2012 | Year | 04 | Month | 14 | Day |
Last modified on
| 2014 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008890
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| Registered date | File name |
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