Unique ID issued by UMIN | UMIN000021944 |
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Receipt number | R000025299 |
Scientific Title | The efficacy and safety of switching from linagliptin to once-weekly dulaglutide in hemodialysis patients with type 2 diabetes mellitus (pilot study) |
Date of disclosure of the study information | 2016/04/26 |
Last modified on | 2016/04/17 09:32:30 |
The efficacy and safety of switching from linagliptin to once-weekly dulaglutide in hemodialysis patients with type 2 diabetes mellitus (pilot study)
The efficacy of linagliptin and dulaglutide in hemodialysis patients with type 2 diabetes mellitus
The efficacy and safety of switching from linagliptin to once-weekly dulaglutide in hemodialysis patients with type 2 diabetes mellitus (pilot study)
The efficacy of linagliptin and dulaglutide in hemodialysis patients with type 2 diabetes mellitus
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism | Nephrology | Adult |
Others
NO
To examine the effects of lingaliptin and once-weekly dulaglutide on glycemic control and safety in hemodialysis patients with type 2 diabetes mellitus
Safety,Efficacy
The amount changes of glycoalbuin and hemoglobin A1c for 26 weeks
The amount changes of daily use insulin in the patients who treated with insulin for 26 weeks
The amount changes of glycoalbuin and hemoglobin A1c for 12 weeks
The amount changes of average body weight before dialysis for one week, self monitoring blood glucose, plasma glucose before hemodialysis, UA, TG, HDL-Cho, LDL-Cho, C-peptide, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The target patients switch from linagliptin to once-weekly 0.75mg dulaglutide. We follow it up for 26 weeks. In the patient using insulin with hypoglycemic risk, insulin dose was adjusted once or twice weekly.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Type 2 diabetes patients who passed more than three months after the dialysis introduction.
2)The patients with linagliptin who satisfy more than 7.0% HbA1c or more than 20.0% glycoalbumin.
3)BMI is more than 22.0kg/m2
1)Patients with severe gastroparesis
2)The patient with the medical history of the pancreatitis
3)Patients who have a medical history of hypersensitivity
4)Pregnant or possibly pregnant women and women on lactation
5)Ineligible patients according to the investigator's judgment
6)The patients who do not agree with this study
20
1st name | |
Middle name | |
Last name | Tetsuya Ogawa |
Tokyo Women`s Medical University Medical Center East
Internal Medicine
2-1-10 Nishiogu Arakawa-ku Tokyo 116-8567 Japan
03-3810-1111
tetsu07jp@gmail.com
1st name | |
Middle name | |
Last name | Tetsuri Yamashita |
Tokyo Women`s Medical University Medical Center East
Internal Medicine
2-1-10 Nishiogu Arakawa-ku Tokyo 116-8567 Japan
03-3810-1111
tetsuri218@yahoo.co.jp
Minamisenju Hospital
Minamisenju Hospital
Self funding
NO
南千住病院(東京都)
2016 | Year | 04 | Month | 26 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 04 | Month | 26 | Day |
2016 | Year | 04 | Month | 27 | Day |
2016 | Year | 04 | Month | 17 | Day |
2016 | Year | 04 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025299
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