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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007595
Receipt No. 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

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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
Email 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
Email hiyamada@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University School of Medicine Department of Cardiovascular Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008967

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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