Unique ID issued by UMIN | UMIN000006098 |
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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 |
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
Miglitol And Sitagliptin on gasTric plypeptide sEcretory Responses in type 2 diabetic patients with obesity (MASTER Study)
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
Miglitol And Sitagliptin on gasTric plypeptide sEcretory Responses in type 2 diabetic patients with obesity (MASTER Study)
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
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
Efficacy
Exploratory
Explanatory
Not applicable
Before and after administration of miglitol, sitagliptin or both
1. changes in plasma incretins
2. changes in body weight and visceral fat mass
HbA1c, 1,5-AG
PYY, DHEAS
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
3
Treatment
Medicine |
miglitol 50 mg thrice a day
sitagliptn once a day
miglitol 50 mg thrice a day and sitgliptin 50 mg once a day
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
45
1st name | |
Middle name | |
Last name | Takuma Narita |
Akita University Garduate School of Medicine
Department of Endocrinology, Diabetes and Geriatric Medicine
Hondo 1-1-1, Akita, Japan
+81-18-884-6769
1st name | |
Middle name | |
Last name | Takuma Narita |
Akita University Garduate School of Medicine
Department of Endocrinology, Diabetes and Geriatric Medicine
Hondo 1-1-1, Akita, Japan
+81-18-884-6769
narita@med.akita-u.ac.jp
Akita University Garduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine
self funding
Self funding
NO
2011 | Year | 08 | Month | 02 | Day |
Unpublished
Completed
2011 | Year | 06 | Month | 30 | Day |
2011 | Year | 07 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 05 | Month | 31 | Day |
2011 | Year | 08 | Month | 02 | Day |
2013 | Year | 08 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007215
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