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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007759
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Nagoya University Hospital Department of Geriatric medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008890

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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