UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shinichi Oikawa
Organization	Nippon Medical School
Division name	Division of Endocrinology and Metabolism, Department of Medicine
Address	1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL	03-3822-2131
Email	shinichi@nms.ac.jp

Public contact
Name of contact person	Shinichi Oikawa
Organization	Nippon Medical School
Division name	Division of Endocrinology and Metabolism, Department of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 09 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007672