UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006465 |
|---|---|
| Receipt number | 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 13:58:18 |
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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
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
shinichi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007672
