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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024865
Receipt No. R000028621
Scientific Title Insulin Degludeg / Insulin Aspart BID injection therapy versus GLP-1 analogue Liraglutide and Insulin Deguldec combination therapy in Tochigi
Date of disclosure of the study information 2016/12/01
Last modified on 2017/10/16

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Basic information
Public title Insulin Degludeg / Insulin Aspart BID injection therapy versus GLP-1 analogue Liraglutide and Insulin Deguldec combination therapy in Tochigi
Acronym IDEAL Trial
Scientific Title Insulin Degludeg / Insulin Aspart BID injection therapy versus GLP-1 analogue Liraglutide and Insulin Deguldec combination therapy in Tochigi
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshimasa Aso
Organization Dokkyo Medical University Hospital
Division name Endocrinology and Metabolism
Zip code
Address 880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL 0282-86-1111
Email yaso@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Suzuki
Organization Dokkyo Medical University Hospital
Division name Endocrinology and Metabolism
Zip code
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)

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
2016 Year 12 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 26 Day
Date of IRB
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

Other
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

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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