UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006098
Receipt number 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 11:02:20

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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