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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006465
Receipt No. R000007672
Scientific Title Comparison and evaluation of different effects of three alpha-Glucosidase inhibitors on lowering blood sugar and body weight in Japanese obese patients with type 2 diabetes
Date of disclosure of the study information 2011/10/04
Last modified on 2018/06/27

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Basic information
Public title Comparison and evaluation of different effects of three alpha-Glucosidase inhibitors on lowering blood sugar and body weight in Japanese obese patients with type 2 diabetes
Acronym Nippon Medical School Group:Clinical Usefulness Research of alpha-glucosidase inhibitor Effect on Type 2 Diabetes Mellitus with Obesity (N-CURE Study)
Scientific Title Comparison and evaluation of different effects of three alpha-Glucosidase inhibitors on lowering blood sugar and body weight in Japanese obese patients with type 2 diabetes
Scientific Title:Acronym Nippon Medical School Group:Clinical Usefulness Research of alpha-glucosidase inhibitor Effect on Type 2 Diabetes Mellitus with Obesity (N-CURE Study)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we compare Miglitol, Acarbose, and Voglibose, with a control group comprised of patients who received no alpha-GI therapy, on their effects on glycemic and weight control and other clinical benefits in Japanese obese patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c,1.5-AG,Body Weight,BMI
Key secondary outcomes FPG,Serum Insulin,HOMA-IR,Adiponectin,Leptin,
Questionnaires(digestive symptoms,appetite,drug compliance)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Miglitol 150mg/day 12weeks
Interventions/Control_2 Voglibose 0.9mg/day 12weeks
Interventions/Control_3 Acarbose 300mg/day 12weeks
Interventions/Control_4 Non-alpha-GI-treated 12weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese patients of both sexes, age 40 or older who were under the care of one of the study centers and who were obese patients with type 2 diabetes with an HbA1c of 6.4% to 8.4% (NGSP) and a body mass index (BMI) of 25 kg/m2 or above.
Key exclusion criteria Patients on insulin therapy and patients with a serious hepatic, renal, or cardiac disease
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Oikawa
Organization Nippon Medical School
Division name Division of Endocrinology and Metabolism, Department of Medicine
Zip code
Address 1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL 03-3822-2131
Email shinichi@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Oikawa
Organization Nippon Medical School
Division name Division of Endocrinology and Metabolism, Department of Medicine
Zip code
Address 1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL 03-3822-2131
Homepage URL
Email shinichi@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization SANWA KAGAKU KENKYUSHO CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 日本医科大学附属病院(東京都)、国民健康保険八丈町立八丈病院(東京都)、自治医科大学附属さいたま医療センター(埼玉県)、乙成内科医院(福岡県)、柏市立柏病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 04 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
2007 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 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 10 Month 04 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007672

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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