UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Title of the study (Brief title)	Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare efficacy and safety of dulaglutide in type 2 diabetes mellitus patients who are formerly treated with sitagliptin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of HbA1c,body weight at the 12th and the 24th week.
Key secondary outcomes	Change of data shown below at the 12th and the 24th week. AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patients are treated with dulaglutide instead of sitagliptin from the start to the 24th week.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes with HbA1c =/> 6.5%
Key exclusion criteria	1. Type 1 diabetes 2. Patients with severe renal failure or liver dysfunction 3. Patients with drug allergy for ipraglifrozin 4. Patients with history of diabetec ketosis 5. Patients with shick day
Target sample size	40

Research contact person
Name of lead principal investigator	Tomoyuki Iwasaki
Organization	Iwasaki Naika Clinic
Division name	Endocrinology and Metabolism
Address	1-1-5-1F Kamihoshikawa, Hodogayaku, Yokohama, Kanagawa, Japan
TEL	045-442-6475
Email	iwasaki11111@gmail.com

Public contact
Name of contact person	Tomoyuki Iwasaki
Organization	Iwasaki Naika Clinic
Division name	Endocrinology and Metabolism
Address	1-1-5-1F Kamihoshikawa, Hodogayaku, Yokohama, Kanagawa, Japan
TEL	045-442-6475
Homepage URL
Email	iwasaki11111@gmail.com

Sponsor
Institute	Iwasaki Naika Clinic
Institute
Department

Funding Source
Organization	Iwasaki Naika Clinic
Organization
Division
Category of Funding Organization	Self funding
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	岩崎内科クリニック

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 20 Day
Anticipated trial start date	2016 Year 07 Month 25 Day
Last follow-up date	2017 Year 04 Month 28 Day
Date of closure to data entry	2017 Year 04 Month 28 Day
Date trial data considered complete	2017 Year 04 Month 28 Day
Date analysis concluded	2017 Year 05 Month 31 Day

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

Management information
Registered date	2016 Year 07 Month 20 Day
Last modified on	2017 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026787