UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Insulin Degludeg / Insulin Aspart BID injection therapy versus GLP-1 analogue Liraglutide and Insulin Deguldec combination therapy in Tochigi
Title of the study (Brief title)	IDEAL Trial
Region	Japan

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

Objectives
Narrative objectives1	Two treatment were compared about efficacy and safety in patients with type 2 diabetes who have inadequate glycemic control despite insulin therapy: twice-dailyInsulin degludec/insulin aspart (IDegAsp) or insulin degludec plus liraglutide.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change from baseline in HbA1c after 26 and 52 weeks of treatment. The achievement rate of HbA1c < 7.0%
Key secondary outcomes	Changes in HbA1c levels (0,12,26,52 weeks) 7 points plasma glucose (Daily profile) (0,12,26,52 weeks) Changes in body weight and BMI (0,12,26,52 weeks) Dosage of insulin and liraglutide (0,12,26,52 weeks) Frequencies of all hypoglycemic episodes Changes in serum C-peptide (0,52 weeks) CD16/TLR4 on blood monocytes (0,52 weeks) Changes in GOT/GPT (0,52 weeks) Change in coefficient of Variation of R-R intervals (0,52 weeks) Changes in urinary albumin excretion (0,52 weeks)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	BID IDegAsp arm Insulin titration: Treat to target (FPG less than 110 mg/dl)
Interventions/Control_2	Insulin degludec plus liraglutide arm The liraglutide dose was titrated to and maintained at 0.9 mg/day. Insulin titration: Treat to target (FPG less than 110 mg/dl)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes Patients who have received insulin therapy more than 3 months HbA1c values between 7.0 and 10.5% Body mass index (BMI) between 17.0 and 40 Patients who gave written informed consent
Key exclusion criteria	Patients who have experienced severe diabeticketosis, diabetic coma, or past history of pre-coma prior to 6 months Patients with severe infections, severe injury or perioperative state. Female patients who have pregnancy or possibilty of pregnancy, or are under lactation Patients who had past history of hypersensitivity or allergic reaction to insulin degludec, aspart or liraglutide Patients with severe liver or renal dysfunction.
Target sample size	80

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo Medical University Hospital
Division name	Endocrinology and Metabolism
Address	880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL	0282-86-1111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Kunihiro Suzuki
Organization	Dokkyo Medical University Hospital
Division name	Endocrinology and Metabolism
Address	880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL	0282-86-1111
Homepage URL
Email	kuni-s@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Other
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 26 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2019 Year 12 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	2016 Year 11 Month 16 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028621