UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of ultralongacting insulin, glargine and degludec in type2 diabetes
Title of the study (Brief title)	Comparison of ultralongacting insulin, glargine and degludec
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 purpose of this study is to compare the effect of glargine and degludec on glycemic control and safety in patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Achievement rate of FPG <110mg/dl and PPG <180mg/dl after treatment with glargine or degludec
Key secondary outcomes	1)Glucose variability, CV. 2)Achievment rate of <110mg/dl of FPG or 180mg/dl of PPG 3)FPG and PPG after 2 weeks of treatment 4)days to achieve target 5)frequencies of hypoglycemia 6)Achievment rate of <130mg/dl of FPG or 200mg/dl of PPG 7)lipid control 8)MAGE and CV in CGM

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	degludec 4units/day and Quick insulin 4units every meals,then doses of insulin is adjusted according to the algorythm.
Interventions/Control_2	Glargine 4units/day
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	1)before test registration - no insulin therapy and inpatient 2)FPG :more than 200mg/dl, PPG:more than 300mg/dl 3)HbA1c :more than 8.0%, less than 14% 4)Type 2 diabetes 5)Age more than 20, less than 85Type 6)Pts with written IC
Key exclusion criteria	1)severe ketosis, diabetic coma within 6 months 2)severe infection, before operation, severe trauma 3)severe hepatic dysfunction 4)or severe renal dysfunction (SCr:more than 2.0mg/dl or eGFR less than 30) 5)pregnacy 6)Allergy for glargine and degludec 7)Patients judged by the investigator to be ineligible for some other reason
Target sample size	70

Research contact person
Name of lead principal investigator	Tadashi Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	yamakat@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Jun Suzuki
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	jsuzuki@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	横浜市立大学附属市民総合医療センター（神奈川県） 藤沢市民病院(神奈川県) 横須賀市立市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 07 Day
Anticipated trial start date	2013 Year 04 Month 09 Day
Last follow-up date	2017 Year 03 Month 31 Day
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

Management information
Registered date	2013 Year 04 Month 09 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012216