UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Insulin combined with the DPP-4 inhibitor sitagliptin for diabetes: evaluation study
Title of the study (Brief title)	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	Yuichiro Yamada
Organization	Akita University Graduate School of Medicine
Division name	Department of Endcrinology, Diabetes and Geriatric Medicine
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	Nobuyuki Shihara
Organization	Japan Association for Diabetes Education and Care
Division name	secretariat
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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