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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006098
Receipt No. R000007215
Scientific Title The study to explore the effecs of miglitol and sitagliptin on the responses of active gastric inhibitory polypeptide responses and the changes in body weight and visceral fat mass in type 2 diabetic patients with obesity
Date of disclosure of the study information 2011/08/02
Last modified on 2013/08/02

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Basic information
Public title The study to explore the effecs of miglitol and sitagliptin on the responses of active gastric inhibitory polypeptide responses and the changes in body weight and visceral fat mass in type 2 diabetic patients with obesity
Acronym Miglitol And Sitagliptin on gasTric plypeptide sEcretory Responses in type 2 diabetic patients with obesity (MASTER Study)
Scientific Title The study to explore the effecs of miglitol and sitagliptin on the responses of active gastric inhibitory polypeptide responses and the changes in body weight and visceral fat mass in type 2 diabetic patients with obesity
Scientific Title:Acronym Miglitol And Sitagliptin on gasTric plypeptide sEcretory Responses in type 2 diabetic patients with obesity (MASTER Study)
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore effects of miglitol and sitagliptin on the responses of active gastric inhibitory polypeptide responses and the changes in body weight and visceral fat mass in type 2 diabetic patients with obesity
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Before and after administration of miglitol, sitagliptin or both
1. changes in plasma incretins
2. changes in body weight and visceral fat mass
Key secondary outcomes HbA1c, 1,5-AG
PYY, DHEAS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 miglitol 50 mg thrice a day
Interventions/Control_2 sitagliptn once a day
Interventions/Control_3 miglitol 50 mg thrice a day and sitgliptin 50 mg once a day
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 1. HbA1c < 10.4 %
2. BMI >= 25
3. diet therapy and/or exerxise thepapy with or without metformin on the conditions of 1 and 2
4. HbA1c <10.4 % and with low dose sulfonyl urea (glimepiride =< 2mg/day, glibenclamide =<1.25 mg/day or gliclazide =< 40 mg/day) on the conditions of 1 and 2
Key exclusion criteria 1. type 1 diabetes
2. with severe or asymptomatic hypoglycemic episodes
3. severe hepatic disorders
4. with viral hepatitis
5. severe renal disease
6. severe heart failure or acute coronay syndrome within the previous 6 months
7. acute or chronic pancreatitis
8. malignant tumors
9. infectious diseases, under consideration of operations or with traumatic diseases
10. severe diabetc neuropathy
11. severe diabetic retinopathy
12. with ketoacidosis or severe hyperglycemic states
13. inflammatory bowel dideases, ileus or past history of ileus
14. chronic bowel diseases with malabsorption
15. with diseases which may grow worth by bowel gas retention
16. gastrectomy
17. lactose intolerance
18. massive alcohol intake
19. pregnacy, lactation or candidates
20. patients under ongoing other clinical trials or under those within 4 months
21. patients who are judged as inappropriate for inclusion by phsicians
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Narita
Organization Akita University Garduate School of Medicine
Division name Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address Hondo 1-1-1, Akita, Japan
TEL +81-18-884-6769
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Narita
Organization Akita University Garduate School of Medicine
Division name Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address Hondo 1-1-1, Akita, Japan
TEL +81-18-884-6769
Homepage URL
Email narita@med.akita-u.ac.jp

Sponsor
Institute Akita University Garduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 02 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
2011 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 02 Day
Last modified on
2013 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007215

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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