Unique ID issued by UMIN | UMIN000003584 |
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Receipt number | R000004345 |
Scientific Title | Switching from sulfonylurea to sitagliptin among type 2 diabetic patients in combination with metformin or pioglitazone. |
Date of disclosure of the study information | 2010/05/10 |
Last modified on | 2013/02/17 16:06:37 |
Switching from sulfonylurea to sitagliptin among type 2 diabetic patients in combination with metformin or pioglitazone.
Switching from sulfonylurea to sitagliptin in combination with metformin or pioglitazone.
Switching from sulfonylurea to sitagliptin among type 2 diabetic patients in combination with metformin or pioglitazone.
Switching from sulfonylurea to sitagliptin in combination with metformin or pioglitazone.
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To know whether switching from sulfonylurea to a DPP-4 inhibitor sitagliptin improves glycemic control among type 2 diabetic patients receiving combination therapies of sulfonylurea + metformin or sulfonylurea + pioglitazone. In addition, to know what factors are involving the achievement of good glycemic control.
Efficacy
Exploratory
Pragmatic
Changes of HbA1c from the base-line to 12 weeks later
Changes from the base-line to 12 weeks later of the following items;
fasting plasma glucose, body weight, fasting insulin, glucagon test CPR (0 and 6 min), fasting GLP-1, fasting GIP, urinary albumin, power spectrum obtained with Fourier analysis of RR-intervals of ECG
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Sitagliptin
50 mg/day (to be stepped up to 100 mg/day when HbA1c increases by >0.5% at 4 or 8 weeks), for 12 weeks
30 | years-old | <= |
70 | years-old | > |
Male and Female
Outpatients of type 2 diabetes satisfying the following all criteria;
1) receiving sulfonylurea + metformin 500 – 1,000 mg/day or sulfonylurea + pioglitazone 15 – 45 mg/day for more than 8 weeks without any changes of doses and regimens
2) with the baseline HbA1c >= 6.5% and <= 9.0%, and <= 0.5% of the difference between -8 or -4 weeks and the baseline
3) having preproliferative or less advanced retinopathy, and early stage of overt proteinuria (< 1.0 g/day) or less advanced nephropathy
4) whose written informed consent is obtainable
Patients satisfying any of the following criteria;
1) receiving or having received sitagliptin
2) having neural diseases (including clinically overt cerebral infarction) but diabetic neuropathy
3) having arrhythmia or heart failure
4) having more than moderate renal dysfunction (sCr > 1.5 mg/dl in men, > 1.3 mg/dl in women)
5) having severe liver dysfunction
6) having malignancy
7) being pregnant, or breast-feeding
8) having any of contraindications for sitagliptin
9) having contraindications for both metformin and pioglitazone
10) suspected as pheochromocytoma, or having allergic history against glucagon
100
1st name | |
Middle name | |
Last name | Hajime NAKABAYASHI |
Kanazawa Munehiro Hospital
Internal Medicine
24-30 Sakuramachi, Kanazawa 920-0923, Japan
1st name | |
Middle name | |
Last name | Atsushi NAKAGAWA |
Kanazawa Medical University Hospital
Department of Endocrinology and Metabolism
1-1 Daigaku, Uchinada 920-0293, Japan
atch-n@kanazawa-med.ac.jp
Hokuriku Incretin-based Therapy Study Group
Research Foundation for Community Medicine
Non profit foundation
NO
金沢医科大学病院(石川県),石川県立中央病院(石川県),富山赤十字病院(富山県),金沢宗広病院(石川県)
2010 | Year | 05 | Month | 10 | Day |
Unpublished
Completed
2010 | Year | 02 | Month | 18 | Day |
2010 | Year | 05 | Month | 01 | Day |
2012 | Year | 03 | Month | 31 | Day |
2012 | Year | 06 | Month | 30 | Day |
2012 | Year | 08 | Month | 31 | Day |
2010 | Year | 05 | Month | 09 | Day |
2013 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004345
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