UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007595 |
|---|---|
| Receipt number | R000008967 |
| Scientific Title | Randomized control clinical trial to evaluate protective effects of combination therapy of ARB and DDP-4 inhibitor on pancreatic beta cell function |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2016/03/29 12:40:55 |
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Basic information
Public title
Randomized control clinical trial to evaluate protective effects of combination therapy of ARB and DDP-4 inhibitor on pancreatic beta cell function
Acronym
Protective effects of combination therapy of ARB and DDP-4 inhibitor on pancreatic beta cell function
Scientific Title
Randomized control clinical trial to evaluate protective effects of combination therapy of ARB and DDP-4 inhibitor on pancreatic beta cell function
Scientific Title:Acronym
Protective effects of combination therapy of ARB and DDP-4 inhibitor on pancreatic beta cell function
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus complicated with essential hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether combination therapy of ARB and DPP-4 inhibitor is more protective than that of ARB and sulfonylurea in terms of pancreatic beta cell function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ratio of pro-insulin to insulin, HOMA-beta
Key secondary outcomes
HbA1c, insulin sensitivity(HOMA-IR), body weight, blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
new administration of DPP-4 inhibitor
Interventions/Control_2
new administration or loading of sulfonylurea
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible outpatients met the following criteria:
1) Hypertensive patients with type 2 diabetes who are treated with ARB.
2) Type 2 diabetic patients taking oral hypoglycemic agents (sulfonylurea) or none with hemoglobin A1c level (JDS) more than 6.1% for at least 2 months.
Key exclusion criteria
Patients are excluded from the study if there is any evidence of type 1 diabetes, treatment with insulin, GLP-1 analog, and other hypoglycemic agent except for sulfonylurea, renal failure (serum creatinine: more than 1.5 mg/dl for male, 1.3 mg/dl for female), severe liver dysfunction, pregnancy and past history of diabetic coma within 6 months.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamada Hiroyuki |
Organization
Kyoto Prefectural University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL
075-251-5511
hiyamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamada Hiroyuki |
Organization
Kyoto Prefectural University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
465 Kjii-cho Kamigyo-ku Kyoto City Japon
TEL
075-251-5511
Homepage URL
hiyamada@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University School of Medicine Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC
Organization
Division
Category of Funding Organization
Non profit foundation
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
Members of Kyoto Lifestyle Study Group: Hajime Shirai (Aiseikai
Yamashina Hospital); Yusuke Nakagawa, Kenzo Sakamoto,
Masaki Tsukamoto (Akashi City Hospital); Sinsaku Matsunaga
(Kyoto City Hospital); Satoshi Gojo, Naohiko Nakanishi (Kyoto
Prefectural University of Medicine); Yoshihiro Matsui, Hirokazu
Yokoi (Japanese Red Cross Kyoto Daiichi Hospital); Sumio
Komatsu (Komatsu Heart Clinic); Morihiko Kondo, ToshiyukiOtomo, Tetsuya Tanaka, Kazuto Yamamoto (Kobe Central
Hospital); Yoshifumi Nakahara (Saiseikai Shigaken Hospital);
Takeshi Takenaka (Takenaka Clinic); Shigeki Kusuoka, Keizo
Furukawa (Tanabe Central Hospital).
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/?term=10.1177%2F1470320315587180
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 | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008967
| Research Plan | |
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| 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 |
