Unique ID issued by UMIN | UMIN000010176 |
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Receipt number | R000011916 |
Scientific Title | The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administration |
Date of disclosure of the study information | 2013/03/06 |
Last modified on | 2017/03/09 09:31:26 |
The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administration
The effects of combination therapy of Vildagliptin and Insulin on diabetes mellitus
The effects of add-on therapy of DPP4 inhibitor, Vildagliptin, on glucose control and diabetic complication in type 2 diabetes mellitus treated with insulin administration
The effects of combination therapy of Vildagliptin and Insulin on diabetes mellitus
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To examine the effects of DPP-4 inhibitor, Vildagliptin, add-on to insulin therapy on glycemic control and diabetic complications in patients with type 2 diabetes mellitus
Safety,Efficacy
Plasma glucose, HbA1c, diabetic retinopathy, diabetic nephropathy, cardiovascular disease, cerebral infarction, fracture, cancer
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Vildagliptin, 50-100mg, once or twice/day, 5 years
no Vildagliptin
Not applicable |
Not applicable |
Male and Female
type 2 diabetes mellitus with insulin therapy
type 1 diabetes mellitus, severe liver injury, heart failure, pancreatitis, ileus
400
1st name | |
Middle name | |
Last name | Ippei Kanazawa |
Shimane University Faculty of Medicine
Endocrinology and Metabolism
89-1 Enya-cho, Izumo, Shimane
0853-20-2183
ippei.k@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Ippei Kanazawa |
Shimane University Faculty of Medicine
Endocrinology and Metabolism
89-1 Enya-cho, Izumo, Shimane
0853-20-2183
ippei.k@med.shimane-u.ac.jp
Shimane University Faculty of Medicine
Shimane University Faculty of Medicine
Self funding
NO
2013 | Year | 03 | Month | 06 | Day |
Published
The baseline characteristics of subjects, including age, dose of insulin injections, or HbA1c levels, did not differ between the two groups. In the vildagliptin group, HbA1c levels significantly decreased and the significance of HbA1c reduction was maintained for 24 months (from 8.0% to 7.4%, p<0.05, at the end of observational period). In addition, the dose and number of insulin injections significantly reduced (-5.6 units, p<0.01, and -0.9 times, p<0.001). However, these parameters were unchanged in the control group. The number of patients who experienced three or more episodes of hypoglycemia per year was significantly lower in the vildagliptin group (n=4) than in the control group (n=11) (odds ratio, 0.28; 95% confidence interval, 0.08-0.97; p<0.05).
Completed
2013 | Year | 02 | Month | 28 | Day |
2013 | Year | 04 | Month | 01 | Day |
2016 | Year | 11 | Month | 15 | Day |
2016 | Year | 11 | Month | 15 | Day |
2013 | Year | 03 | Month | 06 | Day |
2017 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011916
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