UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015466 |
|---|---|
| Receipt number | R000017980 |
| Scientific Title | The efficacy of alogliptin and pioglitazone to gastrin and glycemic control in patients with type 2 diabetes under treatment with gastric secretion inhibitor |
| Date of disclosure of the study information | 2014/10/20 |
| Last modified on | 2015/11/11 14:54:59 |
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Basic information
Public title
The efficacy of alogliptin and pioglitazone to gastrin and glycemic control in patients with type 2 diabetes under treatment with gastric secretion inhibitor
Acronym
The efficacy of alogliptin and pioglitazone to gastrin and glycemic control
Scientific Title
The efficacy of alogliptin and pioglitazone to gastrin and glycemic control in patients with type 2 diabetes under treatment with gastric secretion inhibitor
Scientific Title:Acronym
The efficacy of alogliptin and pioglitazone to gastrin and glycemic control
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By prescribing alogliptin and pioglitazone,examined by drugs that gastric secretion inhibitor,whether there is a difference in gastrin and glycemic control
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes and %changes in gastrin and HbA1c after 6 months from baseline
Key secondary outcomes
Changes and %changes in the following parameters during the observation period
Body weight
Fasting plasma glucose
Office blood pressure
Serum creatinine
HDL
TG
LDL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alogliptin
Interventions/Control_2
Pioglitazone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type2 diabetes whose HbA1c is >6.4% under life style intervention and ordinal dosage of SU or metformin or alpha-glucosidase inhibitor treatment
Key exclusion criteria
severe diabetic ketosis diabetic coma or past history of pre-coma
severe infection before or after operation or serious traumatic injury
past history of hypersensitivity or allergic reaction to alogliptin and pioglitazone
heart failure and past history of heart failure
pregnancy or possibilty of pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Inoue Syuji |
Organization
National Hospital Organization National Kochi Hospital, Kochi, Japan
Division name
Division of Gastroenterology
Zip code
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
TEL
088-844-3111
inouesh@kochi2.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inoue Syuji/Eguthi Sizuka |
Organization
National Hospital Organization National Kochi Hospital, Kochi, Japan
Division name
Division of Gastroenterology
Zip code
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, Japan
TEL
088-844-3111
Homepage URL
inouesh@kochi2.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization National Kochi Hospital, Kochi, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人国立病院機構高知病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 18 | Day |
Last modified on
| 2015 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017980
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
