UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024865 |
|---|---|
| Receipt number | 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 21:53:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kuni-s@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028621
