UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014139 |
|---|---|
| Receipt number | R000016467 |
| Scientific Title | Comparison of efficacy and safety of sitagliptin or ipragliflozin in type 2 diabetic patients with insulin therapy |
| Date of disclosure of the study information | 2014/06/03 |
| Last modified on | 2019/05/08 18:57:02 |
* 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
Comparison of efficacy and safety of sitagliptin or ipragliflozin in type 2 diabetic patients with insulin therapy
Acronym
Administration of sitagliptin or ipragliflozin in type 2 diabetic patients with insulin therapy
Scientific Title
Comparison of efficacy and safety of sitagliptin or ipragliflozin in type 2 diabetic patients with insulin therapy
Scientific Title:Acronym
Administration of sitagliptin or ipragliflozin in type 2 diabetic patients with insulin therapy
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of sitagliptin or ipragliflozin in type 2 diabetic paitents with insulin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c(non-inferiority margin is 0.4%)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Treatment with ipraglifrozin.
Interventions/Control_2
Treatment with sitagliptin.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have HbA1c levels 7 or more %
Key exclusion criteria
Patients whose BMI is less than 18
Patients with moderale renal disfunction
Patients with sever liver disfunction
Patients who have experienced severe diabetic ketosis, diabetic coma, or past history of pre-coma prior to 3 months
Patients with sever infection, operation, trauma, and urine and genital infection
Female patients who have pregnancy or possibilty of pregnancy, or are under lactation
Patients who are considered to be not eligible to the study by the doctor
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aoki |
Organization
Yokohama City University Hospital
Division name
Department of Biostatistics and Epidemiology
Zip code
Address
Fuku-ura 3-9, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
aokikazu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Noguchi |
Organization
Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
Fuku-ura 3-9, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2369
Homepage URL
nikukyu79@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 03 | 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 | 05 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016467
