Unique ID issued by UMIN | UMIN000038459 |
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Receipt number | R000043558 |
Scientific Title | To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes |
Date of disclosure of the study information | 2019/11/01 |
Last modified on | 2021/11/06 00:17:48 |
To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To evaluate the efficacy and safety of sitagliptin for 10 years and to discuss the differences between using sitagliptin and unusing DPP-4 inhibitors.
Safety,Efficacy
Fasting blood glucose and HbA1c are set to be measured at baseline and once at 3 months for 10 years.
Body Mass Index (BMI), blood pressure, albumine creatinine ratio (ACR), lipid and liver function are set to be measured at baseline and once at 3 months for 10 years.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Active treatment with sitagliptin 50mg/day for 10 years
Active treatment except all of DPP-4 inhibitors for 10 years
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Type 2 diabetes
2) eGFR over 30ml/min/1.73m2
3) Diet end exercise are well performed
4) Understanding of the study procedures and consenting to it by signatures
1) Pregnant or being pregnant within the study
2) Contraindication with sitagliptin
40
1st name | Sachiko |
Middle name | |
Last name | Hattori |
Foundation Health Medicine Association Tohto Clinic
Department of Diabetes and Metabolism
102-0094
4-1 Kioi-Cho, Chiyoda-Ku, Tokyo, 102-0094, Japan
03-3239-0301
s-hattori@kenkoigaku.or.jp
1st name | Sachiko |
Middle name | |
Last name | Hattori |
Foundation Health Medicine Association Tohto Clinic
Department of Diabetes and Metabolism
102-0094
4-1 Kioi-Cho, Chiyoda-Ku, Tokyo, 102-0094, Japan
03-3239-0301
s-hattori@kenkoigaku.or.jp
Department of Diabetes and Metabolism,Tohto Clinic
None
Self funding
REC, Tohto Clinic
4-1, Kioi-Cho, Chiyoda-Ku, Tokyo
03-3239-0301
rinri-tohto @kenkoigaku.or.jp
NO
2019 | Year | 11 | Month | 01 | Day |
https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-021-00735-3
Published
https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-021-00735-3
33
The situation is equivalent to improving glycemic control as assessed by HbA1c both in a sitagliptin group (Sit-Gr) (n=17) or a control group (C-Gr) (n=9), while anti-inflammatory effects as assessed by hs-CRP in the Sit-Gr were superior to those in the C-Gr. In the Sit-Gr, ACR was markedly decreased, but no changes in eGFR were seen throughout the study. HOMA-beta was reduced at baseline in both groups, improved significantly in the Sit-Gr, and continued unchanged in the C-Gr during the study.
2021 | Year | 11 | Month | 05 | Day |
This single-center, open-label, randomized, prospective study included a total of 60 T2DM patients, 20-75 years old, with hemoglobin (Hb)A1c 8.0-6.5% and creatinine < 1.2 mg/dl regardless of diet, exercise, and medical treatment without a DPP4i for at least 12 months in this clinic. Patients with type 1 diabetes, unstable cardiac disease, history of cardiovascular disease (CVD), significant renal impairment (creatinine clearance < 30 ml/min), or elevated (more than twice the upper limit of normal) alanine aminotransferase, aspartate aminotransferase, or creatine phosphokinase were excluded. All patients continued medication with oral glucose-lowering drugs (sulfonylureas, metformin, or pioglitazone) that had already been administered. All other medications including antihypertensives (angiotensin II receptor blockers or calcium channel blockers) and antihyperlipidemic agents (statins or fibrates), remained unchanged during the study.
Patients were assigned at random to the sitagliptin group [sitagliptin (50 mg) as either monotherapy or combination therapy with other oral glucose-lowering drugs (n=30)] or the control group [placebo as either monotherapy or other glucose-lowering drugs other than DPP4i (n=22)]. Fasting blood and urine samples were collected before, and every 3 months after intervention for 10 years.
None.
For all patients, blood and urine samples were collected after overnight fasting at baseline and then at intervals of three months for ten years. Assessments of high-sensitivity C-reactive protein (hsCRP), immunoreactive insulin (IRI), and urinary albumin were performed at LSI Medicine Corporation (Tokyo, Japan). Other biochemical data were generated in house. Homeostatic model assessment of insulin resistance (HOMA-IR) was calculated as (fasting blood glucose (FBG) * IRI)/405. Homeostatic model assessment of beta cell function (HOMA-beta) was calculated as (IRI * 360)/(fasting blood glucose (FBG) -63). Data on adverse experiences, physical examinations, vital signs, electrocardiograms, and body weight were collected on each visit.
Completed
2008 | Year | 10 | Month | 03 | Day |
2019 | Year | 10 | Month | 08 | Day |
2008 | Year | 11 | Month | 01 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 11 | Month | 06 | Day |
2019 | Year | 11 | Month | 01 | Day |
2021 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043558
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