Unique ID issued by UMIN | UMIN000045375 |
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Receipt number | R000051813 |
Scientific Title | Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I) |
Date of disclosure of the study information | 2021/09/07 |
Last modified on | 2021/12/20 11:57:17 |
Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)
Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)
Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)
Examination of medication adherence and physical / mental function improvement effect of combination tablets (SGLT2-I and DPP4-I)
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
This study aimed to investigate the effect on the physiological and psychosomatic dysfunctions as well as metabolic dysfunctions by the combination therapy with DPP4 inhibitor and SGLT2 inhibitor for the patients with type 2 diabetes mellitus
Efficacy
Exploratory
Pragmatic
Not applicable
Changes of grip strength
Changes of body weight, HbA1c,blood glucose, blood pressure, circumstance length,GDS15 score,evaluation of psychosomatic activities in IPAQ-SF
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The participants administrating 10 mg/day of empagliflozin or 5 mg/day of linagliptin are followed by empagliflozin/linagliptin combination tablet administration orally.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with glycated haemoglobin (HbA1c) levels higher than 7.0% (National Glycohemoglobin Standardization Program, NGSP) [52 mmol/mol (International Federation of Clinical Chemistry and Laboratory Medicine, IFCC)], and medicated stable with linagliptin or empagliflozin for at least 3 months were included.
Patients with urinary tract infection such as pyelonephritis or with impaired renal function (eGFR [estimated Glomerular filtration rate] less than 30 ml/min/1.73 m2) were excluded
100
1st name | Ayako |
Middle name | |
Last name | Nagayama |
Kurume University School of Medicine
Division of Endocrinology and Metabolism, Department of Internal Medicine
830-0011
67 Asahi-machi, Kurume, Fukuoka, Japan
0942-31-7563
nagayama_ayako@med.kurume-u.ac.jp
1st name | Ayako |
Middle name | |
Last name | Nagayama |
Kurume University School of Medicine
Division of Endocrinology and Metabolism, Department of Internal Medicine
830-0011
67 Asahi-machi, Kurume, Fukuoka, Japan
0942-31-7563
nagayama_ayako@med.kurume-u.ac.jp
Kurume University School of Medicine
Division of Endocrinology and Metabolism, Department of Internal Medicine
None
Self funding
KURUME Medical Study Group of Internal Medicine
Ethics committee of Kurume University School of Medicine
67 Asahi-machi, Kurume, Fukuoka, Japan
0942-65-3749
i_rinri@kurume-u.ac.jp
NO
久留米大学病院(福岡県)、いのくち医院(福岡県)、本間内科循環器内科(福岡県)、稲田内科クリニック(福岡県)、宮崎内科循環器内科(福岡県)、安達医院(福岡県)
2021 | Year | 09 | Month | 07 | Day |
Unpublished
39
No longer recruiting
2019 | Year | 06 | Month | 10 | Day |
2019 | Year | 06 | Month | 10 | Day |
2019 | Year | 09 | Month | 01 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 09 | Month | 04 | Day |
2021 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051813
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