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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010051
Receipt No. R000011735
Scientific Title Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Date of disclosure of the study information 2013/02/28
Last modified on 2015/06/10

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Basic information
Public title Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Acronym Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Scientific Title Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Scientific Title:Acronym Combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To cofirm combined efficacy of DPP-4 inhibitor in type 2 diabetic patients in the medical treatment of Sulfonylurea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Change in HbA1c
Change in weight
Incidence of hypoglycemia
Key secondary outcomes Change in fasting insulin level
Change in fasting blood glucose level
Treatment compliance

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Glimepiride and Sitagliptin
Interventions/Control_2 Increase the amount of Glimepiride
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 Type 2 diabetes patients with inadequate glycemic control Sulfonylurea(Glimepiride:1 or 2mg once a day) monotherapy (HbA1c:6.9% or more, less than 10.5%)
Key exclusion criteria Patients with type 1 diabetes
Patients with a history of severe ketosis, diabetic coma or pre-coma within the past six months
Patients with severe infection, before and after surgery, or severe trauma
Patients with moderate renal impairment or more(serum creatinine level:1.5mg/dl or more(male),1.3mg/dl or more(female))
Patients in the insulin therapy, rapid insulin secretagogue, or alpha-glucosidase inhibitor
Patients with a planned pregnancy or likely to be pregnant or lactating patients, or pregnant patients
Patients with a history of hypersensitivity to study drug
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Yasuda
Organization Osaka Saiseikai Noe Hospital
Division name Department of diabetes and endocrinology
Zip code
Address 1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL 06-6932-0401
Email kyasuda@noe.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoya Koie
Organization Osaka Saiseikai Noe Hospital
Division name Department of diabetes and endocrinology
Zip code
Address 1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL 06-6932-0401
Homepage URL
Email motoya.koie@noe.saiseikai.or.jp

Sponsor
Institute Osaka Saiseikai Noe Hospital
Institute
Department

Funding Source
Organization Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 大阪府済生会野江病院(大阪府)、高石市立診療センター(大阪府)、中村病院(大阪府)、彦根市立病院(滋賀県)、枚方公済病院(大阪府)
Osaka Saiseikai Noe Hospital(Osaka), Takaishi city medical&clinical care center(Osaka), Nakamura Hospital(Osaka), Hikone Municipal Hospital(Shiga), Hirakata kohsai Hospital(Osaka)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 55th Annual Meeting of the Japan Diabetes Society
The 56th Annual Meeting of the Japan Diabetes Society  
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 Main results already published
Date of protocol fixation
2011 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 27 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 15 Day
Last modified on
2015 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011735

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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