Unique ID issued by UMIN | UMIN000006278 |
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Receipt number | R000007430 |
Scientific Title | Comparison of effectiveness of sitagliptin and nateglinide in type 2 diabetes. |
Date of disclosure of the study information | 2011/09/02 |
Last modified on | 2011/09/02 16:40:29 |
Comparison of effectiveness of sitagliptin and nateglinide in type 2 diabetes.
SiTagliptin AND nAteglinide RandomizeD clinical study (STANDARD Study)
Comparison of effectiveness of sitagliptin and nateglinide in type 2 diabetes.
SiTagliptin AND nAteglinide RandomizeD clinical study (STANDARD Study)
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To comfirm the efficacy and safety of sitagliptin in comparison with nateglinide in type 2 diabetes whose glycemic control is insufficiet with diet and exercise therapy.
Efficacy
HbA1c, Apo-B48, TG, glucose
GA, 1,5-AG, insulin, glucagon, adiponectin, Apo-A1, Apo-C3, Apo-B
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Sitagliptin treatment, 3 months
Glinides treatment, 3 months
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 6.1 % 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.Contraindication for sitagliptin.
2.Contraindication for nateglinide.
3.Pregnant or possible pregnant.
4.Patients with sever liver failure or renal failure.
5.Patients considered not eligible for the study by the attending doctor due to other reasons.
40
1st name | |
Middle name | |
Last name | Yuichi Kojima |
Japanese Red Cross Medical Center
Division of Diabetes and Endcrinolgy
4-1-22, hiro-o, shibuya-ku, tokyo 150-8935 JAPAN
1st name | |
Middle name | |
Last name | Yuichi Kojima |
Japanese Red Cross Medical Center
Division of Diabetes and Endcrinolgy
03-3400-1311
Japanese Red Cross Medical Center
Japanese Red Cross Medical Center
Self funding
NO
2011 | Year | 09 | Month | 02 | Day |
Unpublished
Completed
2010 | Year | 07 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2011 | Year | 09 | Month | 02 | Day |
2011 | Year | 09 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007430
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