UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006204 |
|---|---|
| Receipt number | 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 14:37:25 |
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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
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
t-suzuki@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007334
| 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 |
