Unique ID issued by UMIN | UMIN000005508 |
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Receipt number | R000004943 |
Scientific Title | Effects of sitaglyptin 100mg on glucose cotrol in patients with type2 diabetes compared with sitaglyptin 50mg with sulphonylurea or alpha-glucosidase inhibitor |
Date of disclosure of the study information | 2011/04/26 |
Last modified on | 2012/04/25 16:50:54 |
Effects of sitaglyptin 100mg on glucose cotrol in patients with type2 diabetes compared with sitaglyptin 50mg with sulphonylurea or alpha-glucosidase inhibitor
Treatment of type2 diabetic patients with sitaglyptin or sitaglyptin with sulphonylurea or alpha-glucosidase inhibitor
Effects of sitaglyptin 100mg on glucose cotrol in patients with type2 diabetes compared with sitaglyptin 50mg with sulphonylurea or alpha-glucosidase inhibitor
Treatment of type2 diabetic patients with sitaglyptin or sitaglyptin with sulphonylurea or alpha-glucosidase inhibitor
Japan |
type2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To evaluate effects of sitaglyptin on glucose control and endothelial function in patients with type2 diabetes and compare with sitaglyptin with sulphonylurea or alpha-glucosidase inhibitor
Efficacy
Confirmatory
Pragmatic
Not applicable
glucose control
endothelial function, oxidative stress
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
3
Treatment
Medicine |
Dose of sitaglyptin increased from 50mg/d to 100mg/d (3-month administration)
Glimepiride 1m/d add to sitaglyptin 50mg/d (3-month administration)
Acarbose 300mg/d or voglibose 0.6mg/d add to sitaglyptin 50mg/d (3-month administration)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Diabetic patients who administrated sitaglyptin 50mg/d for 3 months or more, and still poor control of plasma glucose.
1. Pregnant or lactating women
2. Diabetes mellitus patients with unstable glycemic control whose HbA1c is more than 8.0%. Or complicated with diabetic nephropathy more than stage3.
3. Patient who is intolerate or allergic againts sitaglyptin, glimepiride, acarbose or voglibose
4. Patient who has kidney or liver dysfunction
5. Type 1 diabetes mellitus
6. Patient who suffered from ketoacidosis or diabetic coma during 3 months. Or patient who has a history of deep coma.
7. Patient who has a severe infection, an operation, or severe injury.
75
1st name | |
Middle name | |
Last name | Yoshiyu Takeda |
Kanazawa University Hospital
Department of Endocrinology and Metabolism
13-1 Takara-machi
076-265-2252
1st name | |
Middle name | |
Last name | Yoshiyu Takeda |
Kanazawa University Hospital
Department of Endocrinology and Metabolism
13-1 Takara-machi
076-265-2252
Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
None
Self funding
NO
金沢大学附属病院(石川県)
2011 | Year | 04 | Month | 26 | Day |
Unpublished
Preinitiation
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2011 | Year | 04 | Month | 25 | Day |
2012 | Year | 04 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004943
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