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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011346
Receipt No. 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

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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
Email 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
Email shihara@nittokyo.or.jp

Sponsor
Institute Japan Association for Diabetes Education and Care
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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