UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004925 |
|---|---|
| Receipt number | R000005860 |
| Scientific Title | The efficacy and safety of direct renin inhibitor aliskiren on the blood glucose control of DPP-IV inhibitor |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2012/07/21 14:11:54 |
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Basic information
Public title
The efficacy and safety of direct renin inhibitor aliskiren on the blood glucose control of DPP-IV inhibitor
Acronym
The efficacy and safety of direct renin inhibitor aliskiren on the blood glucose control of DPP-IV inhibitor
Scientific Title
The efficacy and safety of direct renin inhibitor aliskiren on the blood glucose control of DPP-IV inhibitor
Scientific Title:Acronym
The efficacy and safety of direct renin inhibitor aliskiren on the blood glucose control of DPP-IV inhibitor
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
hypertension
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of direct renin inhibitor aliskiren on the blood glucose lowering effect of DPP-IV inhibitor in type 2 diabetic patients complicated with hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The value of HbA1c at the endopoitn of the trial
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
direct renin inhibitor aliskiren
Interventions/Control_2
amlodipine
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who showed written informed consent to take part in this trial
2. Ptients who take ACE inhibitor or ARB for 3 months or longer
3. Ptients who take DPP-IV inhibitor for 3 months or longer
4. Patients whose HbA1c is between 5.8% and 7%
5. Patients who cannnot achieve the blood pressure treatment goal of 130/80 mmHg
Key exclusion criteria
1. type 1 diabetes mellitus
2. Patients who take both ACE inhibitor and ARB
3. Ptients who have allergy to the study drugs
4. Severe hypertension (180/110 mmHg or higher)
5. Pregnant women, women who want to be pregnant
6. Patients taking cyclosporine
7. Sever liver dysfunction (GOT>80 IU/L, GPT>80 IU/L), renal dysfunction (Cr>1.5(male), 1.4 (female) mg/dl)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Masami |
Organization
School of Medicine, Keio University
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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 | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 21 | Day |
Last modified on
| 2012 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005860
| 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 |
