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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006204
Receipt No. R000007334
Scientific Title The effect of Colestimide on Incretin in patients with Type 2 diabetes mellitus with Hypercholesterolemia
Date of disclosure of the study information 2011/08/20
Last modified on 2014/08/27

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Basic information
Public title The effect of Colestimide on Incretin in patients with Type 2 diabetes mellitus with Hypercholesterolemia
Acronym The effect of Colestimide on Incretin in patients with Type 2 diabetes mellitus with Hypercholesterolemia
Scientific Title The effect of Colestimide on Incretin in patients with Type 2 diabetes mellitus with Hypercholesterolemia
Scientific Title:Acronym The effect of Colestimide on Incretin in patients with Type 2 diabetes mellitus with Hypercholesterolemia
Region
Japan

Condition
Condition hypercholesterolemia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of Colestmide on the lowering activity of plasma glucose and incretin with a mixed meal (Calorie Mate) in patients with type 2 diabetes mellitus and hypercholesterolemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in the plasma glucose, IRI and Incretin before administration of Colestimide and 0, 30, 60, 90 and120 min after taking Calorie Mate
Key secondary outcomes FFA
Serum Lipids
Bile acid compounds

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pravastatin group Pravastatin 10mg
Interventions/Control_2 Colestimide group Colestimide 1.5 g/day
Interventions/Control_3 Healthy Control group No administration
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetic patients whose serum LDL-C level was>=120mg/dL before entry.
2) Type 2 diabetic patients whose serum HbA1c was >=6.5% (JDS) before entry.
Key exclusion criteria 1) Patients who are administered statins except Pravastatin.
2) Patients who are administered insulin.
3) Patients who are administered steroid.
4) Patients who started treatment for diabetes or hyperlipidemia within 3 month before entry.
5) Patients with complete biliary obstruction.
6) Patients who have a history of hypersensitivity for Colestimide.
7) Patients with intestinal obstruction.
8) Patients with hyper- or hypothyroidism.
9) Patients who are pregnant or lactating.
10) Patients who are judged to be inadequate to participate in this study by their physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenzo Ohba
Organization Nippon Medical School Hospital
Division name Geriatric Medicine
Zip code
Address 1-1-5, Sendagi Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Email oba@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Suzuki
Organization Nippon Medical School Hospital
Division name Geriatric Medicine
Zip code
Address 1-1-5, Sendagi Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Homepage URL
Email t-suzuki@nms.ac.jp

Sponsor
Institute Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
Institute
Department

Funding Source
Organization Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated 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
2011 Year 08 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
2010 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2014 Year 08 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 20 Day
Last modified on
2014 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007334

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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