Unique ID issued by UMIN | UMIN000034426 |
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Receipt number | R000039259 |
Scientific Title | Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy using continuous glucose monitoring |
Date of disclosure of the study information | 2018/10/09 |
Last modified on | 2022/11/18 09:15:01 |
Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy using continuous glucose monitoring
Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy
Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy using continuous glucose monitoring
Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare between glycemic variability of patients in whom voglibose is added to metformin, vildagliptin, tofoglifrozin, and insulin glargine 300 U/ml (glargine 300) and glycemic variability of patients in whom pioglitazone is added to those.
Efficacy
24-h Percentage of time in target range (70~180 mg/dL)
24-h Mean absolute glucose (MAG)
24-h Glycemic variability percentage (GVP)
Mean glucose level (24:00, 0:00-6:00, 8:00-24:00)
Standard deviation (SD) (24:00, 0:00-6:00, 8:00-24:00)
Coefficient of variation (CV) (24:00, 0:00-6:00, 8:00-24:00)
High blood glucose index (HBGI)
low blood glucose index (LBGI)
Percentage of time in range (<70 mg/dL)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
40 outpatients with type 2 diabetes treated with metformin 1000mg, vildagliptin 100mg, tofoglifrozin 20mg, and glargine 300 for 3 month or longer are randomly allocated into 2 groups.
Group 1: Voglibose is added to outpatients who agree to participate this study; next, glargine 300 injected at 8 am are titrated with an algorithm for 2 weeks; the dose of glargine 300 is then maintained for 2 week and fasting glcose levels are stabilized. (final registration criteria)
1 month after voglibose or pioglitazone are added, during hospitalization, patients wear a continuous glucose monitoring device (iPro2) and glycemic variability is evaluated on day3.
40 outpatients with type 2 diabetes treated with metformin 1000mg, vildagliptin 100mg, tofoglifrozin 20mg, and glargine 300 for 3 month or longer are randomly allocated into 2 groups.
Group 2:
Pioglitazone is added to outpatients who agree to participate this study; next, glargine 300 injected at 8 am are titrated with an algorithm for 2 weeks; the dose of glargine 300 is then maintained for 2 week and fasting glcose levels are stabilized. (final registration criteria)
1 month after voglibose or pioglitazone are added, during hospitalization, patients wear a continuous glucose monitoring device (iPro2) and glycemic variability is evaluated on day3.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
type 2 diabetes treated with metformin 1000mg, vildagliptin 100mg, tofoglifrozin 20mg, and insulin glargine 300 U/ml for 3 month or longer
patients who cannot achive the final registration criteria.
severe renal dysfunction (eGFR less than 45)
judged to be unsuitable for participation for medical reasons
40
1st name | Soichi |
Middle name | |
Last name | Takeishi |
Inuyama Chuo General Hospital
Diabetes
484-8511
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
1st name | Soichi |
Middle name | |
Last name | Takeishi |
Inuyama Chuo General Hospital
Diabetes
484-8511
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
Inuyama Chuo General Hospital
Inuyama Chuo General Hospital
Self funding
Inuyama Chuo General Hospital
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
NO
2018 | Year | 10 | Month | 09 | Day |
Unpublished
36
Completed
2018 | Year | 10 | Month | 05 | Day |
2018 | Year | 10 | Month | 27 | Day |
2018 | Year | 11 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2018 | Year | 10 | Month | 09 | Day |
2022 | Year | 11 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039259
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