UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011346 |
|---|---|
| Receipt number | R000013290 |
| Scientific Title | Insulin combined with the DPP-4 inhibitor sitagliptin for diabetes: evaluation study |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2018/05/16 19:26:26 |
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Basic information
Public title
Insulin combined with the DPP-4 inhibitor sitagliptin for diabetes: evaluation study
Acronym
I-UNITE Study
Scientific Title
Insulin combined with the DPP-4 inhibitor sitagliptin for diabetes: evaluation study
Scientific Title:Acronym
I-UNITE Study
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of sitagliptin add-on therapy for type 2 diabetes patients with insulin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Efficacy
(1)HbA1c and blood glucose at 0, 3, 6 months and 1, 2 years after starting sitagliptin add-on therapy
(2)Information of insulin therapy
2 Safety
Hypoglycemia and other adverse events and those rates of occurrence
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1 Type 2 diabetes patients
2 Over twenty years of age
3 Receiving sitagliptin add-on therapy with insulin therapy under usual care
4 Continuing constant diabetes treatment before the sitagliptin add-on therapy more than three months.
Key exclusion criteria
1 Hypersensitivity to sitagliptin
2 Patients who had severe ketosis or diabetic coma within 6 months
3 Severe infection or trauma, perioperative
4 Patients whose participation is deemed inappropriate at the discretion of the attending physician
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamada |
Organization
Akita University Graduate School of Medicine
Division name
Department of Endcrinology, Diabetes and Geriatric Medicine
Zip code
Address
1-1-1 Hondo, Akita 010-8543, Japan
TEL
018-884-6769
yamada@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shihara |
Organization
Japan Association for Diabetes Education and Care
Division name
secretariat
Zip code
Address
2-2-4 Kojimchi, Chiyoda-Ku, Tokyo, 102-0083 Japan
TEL
03-3514-1721
Homepage URL
http://www.nittokyo.or.jp/about/research/report/detail.php?t=1&p=12
shihara@nittokyo.or.jp
Sponsor or person
Institute
Japan Association for Diabetes Education and Care
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A survey of commercially available drugs performed by physicians on a voluntary basis
Management information
Registered date
| 2013 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013290
