Unique ID issued by UMIN | UMIN000021953 |
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Receipt number | R000025287 |
Scientific Title | Differences about effectiveness of CGM and treatment satisfaction between dulaglutide and omarigliptin. |
Date of disclosure of the study information | 2016/04/18 |
Last modified on | 2018/09/07 17:39:01 |
Differences about effectiveness of CGM and treatment satisfaction between dulaglutide and omarigliptin.
Effectiveness of CGM and DTSQ with dulaglutide or omarigliptin.
Differences about effectiveness of CGM and treatment satisfaction between dulaglutide and omarigliptin.
Effectiveness of CGM and DTSQ with dulaglutide or omarigliptin.
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To study about effectiveness of continuous glucose monitor (CGM) and treatment satisfaction, we evaluate blood glucose transition with CGM for more than 7 days. The patients would be treated with dulaglutide and omarigliptin.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Blood glucose transition (standard deviation and MAGE) by CGM, average blood glucose level, Diabetes Treatment Satisfaction: DTSQ
glycoalbumin, the total time that blood glucose level monitored by CGM is less than 70mg/dL, body weight, systolic pressure, diastolic pressure, urine albumin creatinine ratio, C-peptide.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
In both groups, we stop the treatment of DPP-4i or GLP-1 receptor agonists if the patients are treated with them, but we continue the treatment with other antidiabetic drugs.
Only this group, No pharmaceutical intervention for 4 weeks, omarigliptin 25 mg/week for 5 weeks, no pharmaceutical intervention for 4 weeks, dulaglutide 0.75 mg/week for 5 weeks and no pharmaceutical intervention for 1 week.
In both groups, patients are equipped with a CGM (iPro2 Enlite Sensor by Medtronic) for 7 days from the 3th week after starting study and for 14 days from at 25th day (3 days before 5th treatment) after treatment with each medicine. We conduct DTSQ at the 4th week after starting study and treatment with each medicine. At the 4th week after starting study and treatment with each medicine, we measure these following values on an empty stomach, body weight, BMI, systolic pressure, diastolic pressure, HbA1c, glycoalbmin, serum AST, ALT, gamma-GTP, BUN, UA, eGFR, urine albumin creatinine ratio(mg/gCr), LDL-C, HDL-C, TG, glucose level, insulin, C-peptide. Office clerks enter inspection data, rather than a doctor.
No pharmaceutical intervention for 4 weeks, dulaglutide 0.75 mg/week for 5 weeks, no pharmaceutical intervention for 4 weeks, omarigliptin 25 mg/week for 5 weeks and no pharmaceutical intervention for 1 week.
15 | years-old | <= |
85 | years-old | > |
Male and Female
Out-patients with type 2 diabetes whose HbA1c is more than 6.5% and less than 15% and who has no changes of diabetic treatment (e.g. diet therapy, exercise cure, medication) within the past 12 weeks.
1. Patients who has renal dysfunction (eGFR is less than 30ml/min/1.73m2)
2. Pregnant women
3. Patients judged by the doctor to be ineligible
20
1st name | |
Middle name | |
Last name | Takahiro Tosaki |
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Diabetes and Endocrinology
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
052-800-2333
nrd49075@nifty.com
1st name | |
Middle name | |
Last name | Takahiro Tosaki |
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Diabetes and Endocrinology
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
052-800-2333
nrd49075@nifty.com
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Self funding
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
NO
医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI (愛知県)
2016 | Year | 04 | Month | 18 | Day |
Partially published
Open public recruiting
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 04 | Month | 18 | Day |
2018 | Year | 05 | Month | 31 | Day |
2016 | Year | 04 | Month | 17 | Day |
2018 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025287
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