Unique ID issued by UMIN | UMIN000013218 |
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Receipt number | R000015424 |
Scientific Title | Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA) |
Date of disclosure of the study information | 2014/02/21 |
Last modified on | 2018/08/03 05:40:31 |
Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Japan |
Type 2 diabetes
Cardiology | Endocrinology and Metabolism |
Others
NO
To examine the efficacy of Sitagliptin for improving hyperglycemia, lipoprotein metabolism and lipid oxidation markers (HETE, HODE, etc.) in patients with type 2 diabetes
Efficacy
Confirmatory
Pragmatic
Not applicable
Changes in the following items will be evaluated at the beginning of administration and after the 12th week of administration.
- Lipid oxidation markers (HODE, HETE)
-Evaluation of following levels before and after the administration of Sitagliptin
>Fasting Glucose
>HbA1c(NGSP or JDS)
>Triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol
>adiponectin, insulin, glucagon
>free fatty acids(FFA)
>apolipoproteinAI, AII, B, CII, CIII, E, apoB-48
>omentin, RemL-C, CystatinC, endotoxin
- Incidence of side effects (hypoglycemia)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
One 50-mg tablet of Sitagliptin will be orally administered once daily for 12 weeks. Based on the therapeutic target, the dose can be increased to 100 mg.
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with type 2 diabetes aged >20 years old who meet the following criteria and have fasting blood glucose (FPG) >126 mg/dL and HbA1c <8.4% (NGSP) or <8.0% (JDS)
Patients who have not shown a sufficient response to any of the following treatments described in the package insert
1) Diet therapy and exercise therapy only
2) Use of a sulfonylurea drug in addition to diet therapy and exercise therapy
Sulfonylurea drug (Amaryl, Euglucon, Glimicron and Daonil)
Patients who meet the following exclusion criteria will be excluded.
3) Use of a thiazolidine drug in addition to diet therapy and exercise therapy
Thiazolidine drug (Actos)
4) Use of a biguanide drug in addition to diet therapy and exercise therapy
Biguanide drug (Melbin, Glycoran, Dibetos B and Metgluco)
5) Use of an alpha-glucosidase inhibitor in addition to diet therapy and exercise therapy
alpha-glucosidase inhibitor (Basen, Seibule and Glucobay)
6) Use of an insulin product in addition to diet therapy and exercise therapy
2. Patients who give written informed consent to participate in the study on a voluntary basis after receiving and understanding a sufficient explanation of the study
1. Patients with type 1 diabetes
2. Patients with severe renal disorder (including hemodialysis) with a serum creatinine (Cr) level (mg/dL) >2.5 for males and >2.0 for females
3. Patients who have already received a sulfonylurea drug at a higher dose than the following dose: (Amaryl: 2 mg, Euglucon: 1.25 mg, and Glimicron: 40 mg), when it is clinically judged that the dose of the sulfonylurea cannot be decreased when sitagliptin is added. The criteria for a decrease in the dose of the sulfonylurea when sitagliptin is added are as follows:
For patients who receive glimepiride (Amaryl) at a dose of >2 mg/day, the dose should be decreased to <2 mg/day.
For patients who receive glibenclamide (Euglucon and Daonil) at a dose of >1.25 mg/day, the dose should be decreased to <1.25 mg/day.
For patients who receive gliclazide (Glimicron) at a dose of >40 mg/day, the dose should be decreased to <40 mg/day.
4. Patients who have already taken Sitagliptin, Alogliptin, or Vildagliptin.
5. Patients who newly started taking a statin, fibrate, ezetimibe, or probucol within 1 month of the start of the study
6. Patients who are pregnant or may become pregnant
7. Patients receiving treatment for thyroid failure
8. Patients with severe hepatic dysfunction with AST and ALT >100 IU/L
9. Patients who have participated in another clinical study
10. Other patients who judged not to be eligible to participate in the study by their primary physician
100
1st name | |
Middle name | |
Last name | Shizuya Yamashita |
Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine
2-2 Yamadaoka, Suita, Osaka
06-6879-3633
shizu@cardiology.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Daisaku Masuda |
Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine
2-2 Yamadaoka, Suita, Osaka
06-6879-3633
masuda@cardiology.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine
The Supporting Center for Clinical Research and Education
Non profit foundation
Japan
NO
大阪中央病院(大阪府)、蒼生病院(大阪府)、リョーヤコマツクリニック(大阪府)
2014 | Year | 02 | Month | 21 | Day |
Published
https://www.jstage.jst.go.jp/browse/jat
In patients with type II diabetes mellitus, fasting and postprandial hypertriglyceridemia (PHTG) is complicated. PHTG is supposed to be caused by the postprandial accumulation of remnant lipoproteins (VLDL remnants and chylomicron remnants), which are highly atherogenic. In the current study, we investigated whether the sitagliptin might ameliorate the impaired lipoprotein metabolism in patients with type II diabetes mellitus. We enrolled 38 patients with type II diabetes mellitus whose HbA1c levels were less than 8.4% and all patients gave written informed consents. The oral administration of sitagliptin(50mg/day) were started in addition to the current anti-diabetic treatments. The daily dose of sitagliptin was allowed to increase up to 100 mg/day in order to achieve low HbA1c level less than 7.4%. We compared biomarkers concerning glucose and lipoprotein metabolism before and after the administration of sitagliptin for twelve weeks. There were significant decreases in fasting glucose levels and HbA1c levels as well as fasting TG levels and non HDL-C levels. Biomarkers of remnant lipoproteins, fasting apolipoprotein(apo) B-48 and RemL-C levels were significantly decreased by sitagliptin. Moreover, there were significant decreases in other apolipoproteins such as apoB, apoC2, C3 and apoE. Cholesterol and TG concentrations of lipoprotein fractions in the size of VLDL and LDL were significantly decreased by sitagliptin assessed by the high performance liquid chromatography(HPLC) analysis. These findings indicated that the administration of sitagliptin improved the lipid and lipoprotein profile in patients with type II diabetes mellitus, which might be due to the decrease in atherogenic remnant lipoproteins.
Completed
2012 | Year | 06 | Month | 14 | Day |
2012 | Year | 07 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2014 | Year | 02 | Month | 21 | Day |
2018 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015424
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