UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011277
Receipt No. R000013216
Scientific Title he efficacy of alogliptin to gastrin and glycemic control in patients with type 2 diabetes under treatment with gastric secretion inhibitor and gastroprotective agents
Date of disclosure of the study information 2013/07/26
Last modified on 2014/10/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title he efficacy of alogliptin to gastrin and glycemic control in patients with type 2 diabetes under treatment with gastric secretion inhibitor and gastroprotective agents
Acronym The efficacy of alogliptin to gastrin and glycemic control
Scientific Title he efficacy of alogliptin to gastrin and glycemic control in patients with type 2 diabetes under treatment with gastric secretion inhibitor and gastroprotective agents
Scientific Title:Acronym The efficacy of alogliptin to gastrin and glycemic control
Region
Japan

Condition
Condition Patients with type 2 diabetes
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By prescribing alogliptin,examined by drugs that gastric secretion inhibitor and gastroprotective agents,or 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
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 hydrochloride
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 diabetic ketosis
severe infection
before and after operation patients with severe trauma
past history of allergy against alogliptin
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Syuuji Inoue
Organization National Hospital Organization National Kochi Hospital,
Division name Division of Gastroenterology
Zip code
Address 1-2-25Asakuranisimati,Kochi,Japan
TEL 088-844-3111
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Syuuji Inoue
Organization National Hospital Organization National Kochi Hospital, Kochi, Japan
Division name Division of Gastroenterology
Zip code
Address 1-2-25Asakuranisimati,Kochi,Japan
TEL
Homepage URL
Email

Sponsor
Institute National Hospital Organization National Kochi Hospital,
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Limited
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
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 26 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
2013 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 26 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
2013 Year 07 Month 25 Day
Last modified on
2014 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.