Unique ID issued by UMIN | UMIN000009445 |
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Receipt number | R000011094 |
Scientific Title | Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study) |
Date of disclosure of the study information | 2012/12/01 |
Last modified on | 2017/06/28 17:06:34 |
Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study)
Combination-effect of alogliptin and lansoprazole (APPLE study)
Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study)
Combination-effect of alogliptin and lansoprazole (APPLE study)
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes using multicenter, randomized -controlled trial-design
Efficacy
Confirmatory
Pragmatic
HbA1c and fasting plasma glucose (FPG)
levels 3 months after starting the study
Fasting gastrin and insulin levels, HOMA-R, HOMA-beta, Body weight 3 months after starting the study
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
3 months-observation by alogliptin treatment
3 months-observation by combination treatment with alogliptin and lansoprazole
20 | years-old | <= |
Not applicable |
Male and Female
1) patients aged 20 or over
2) patients diagnosed as type 2 diabetes
3)outpatient
4)patients with 6.5% and over of HbA1c levels, and plus, with 0.5% or less variation of HbA1c in 1 month before starting administration of drugs
5)patients who did not receive DPP4 inhibitors during 1 month before starting study
6) patients in whom type and dose of all anti-diabetic drugs was not changed during 1 month before starting study
7)patients giving consent in writing for participation for this study
1)Patients with severe ketosis, diabetic coma or diabetic pre-coma, or type 1 diabetes
2)Patients with severe infectious diseases, within 1 month after operation, or having severe traumatic injury
3)Patients with allergy for component of alogliptin or lansoprazole
4)Patients under atazanavir-treatment
5)Patients treated with PPIs of all types or H2-blockers of all types
6)Furthermore, patients judged as inadequacy for participation in this study by medical doctor
100
1st name | |
Middle name | |
Last name | Kohzo Takebayashi |
Dokkyo Medical University Koshigaya Hospital
Internal Medicine (Diabetes, Endocrinology,Hematology)
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
048-965-1111
1st name | |
Middle name | |
Last name | Kohzo Takebayashi |
Dokkyo Medical University Koshigaya Hospital
Internal Medicine (Diabetes, Endocrinology,Hematology)
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
048-965-1111
takebaya@dokkyomed.ac.jp
Dokkyo Medical University Koshigaya Hospital
Dokkyo Medical University Koshigaya Hospital
Self funding
JAPAN
NO
獨協医科大学越谷病院(埼玉県)
2012 | Year | 12 | Month | 01 | Day |
Published
Completed
2012 | Year | 10 | Month | 30 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 08 | Month | 31 | Day |
2014 | Year | 03 | Month | 01 | Day |
2012 | Year | 11 | Month | 30 | Day |
2017 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011094
Research Plan | |
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Research case data | |
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