Unique ID issued by UMIN | UMIN000005376 |
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Receipt number | R000006380 |
Scientific Title | Comparison of effect of sitagliptin and nateglinide on postprandial glucose level and secretion of insulin and glucagon after meal tolerance test in early type 2 diabetes |
Date of disclosure of the study information | 2011/04/04 |
Last modified on | 2012/06/02 12:04:31 |
Comparison of effect of sitagliptin and nateglinide on postprandial glucose level and secretion of insulin and glucagon after meal tolerance test in early type 2 diabetes
Comparison of effectiveness of glinide and DPP-4 inhibitor in early type 2 diabetes
Comparison of effect of sitagliptin and nateglinide on postprandial glucose level and secretion of insulin and glucagon after meal tolerance test in early type 2 diabetes
Comparison of effectiveness of glinide and DPP-4 inhibitor in early type 2 diabetes
Japan |
early type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To comfirm the efficacy and safety of sitagliptin in comparison with nateglinide in early type 2 diabetes whose glycemic control is insufficiet with diet and exercise therapy.
Safety,Efficacy
To clarify which drug show more effective on glucose lowering after meal test between sitagliptin and nateglinide in the same patients?
How each drug influences on insulin, glucagon or other glucose regulation hormones' secriton.
To clarify the effect of each drug on inflammatory cytekine level after the treatent
To comfirm frequency of hypoglycemia after the treatment
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
Institution is not considered as adjustment factor.
2
Treatment
Medicine |
one dose of 100mg of sitagliptine
one dose of 90mg of nateglinide
20 | years-old | <= |
Not applicable |
Male and Female
the patients whose HbA1c level is more than 6.5% even after diet, excise.
1.the patients whose HbA1c are between 6.5 % and 8.0%.
2.the patients whose fasting glucose is less than 140 mg/dL.
3.the patients who have already started diet and exercise therapy for more than 3 months.
4.patients who are more than 20 year-old.
5.no restriction on sex
6.the patients who are able to read and understand the written informed consent.
1) type 1 diabetes
2) patients who has been prescribed oral hypoglycemic agents
3) patients who have serious liver disease (AST and/or ALT are more than 100IU/L)
4) patients who have serious kidney disease (Serum Cr is more than 2.0mg/dL)
5) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months)
6) patients who have serious pancreatic disease
7) patients with cancer
8) anemic patients (Hb is less than 11g/dL)
9) patients with thrombocytepenia (Platelet count is less than 100000/mm3)
10) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
11) patietns with serious infection, inflammation, or injuary. pre- or post- operative state
12) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus
13) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome
14) patients who has the disease which is deteriorated with increase of gas in bowel
15) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day)
16) patients who are pregnant, hope to be pregnant, or are in lactation period
17) patients who have viral infection (HBV,HCV)
18) patients who are not applicable to this study judged by the medical doctor.
20
1st name | |
Middle name | |
Last name | Takahisa Hirose M.D. and Ph.D |
Juntendo University Graduate School of Medicine
Department of Metabolisma and Endocrinology
2-1-1 Hongo Bunkyo-ku Tokyo
1st name | |
Middle name | |
Last name |
Juntendo University Graduate School of Medicine
Department of Metabolism and Endocrinology
03-5802-1579
Juntendo University Graduate School of Medicine
none
Self funding
NO
2011 | Year | 04 | Month | 04 | Day |
Unpublished
Completed
2010 | Year | 05 | Month | 11 | Day |
2010 | Year | 06 | Month | 01 | Day |
2011 | Year | 04 | Month | 04 | Day |
2012 | Year | 06 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006380
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