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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011827
Receipt No. R000013824
Scientific Title Insulin Deguldec versus Glargine Once in Tochigi
Date of disclosure of the study information 2013/09/20
Last modified on 2019/09/25

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Basic information
Public title Insulin Deguldec versus Glargine Once in Tochigi
Acronym I'd Got Trial
Scientific Title Insulin Deguldec versus Glargine Once in Tochigi
Scientific Title:Acronym I'd Got Trial
Region
Japan

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

Objectives
Narrative objectives1 To determine whether insulin deguldec is noninferior to insulin glargine with respect to glycemic control in patients with type 2 diabetes who have inadequate glycemic control despite oral therapy

To assess the effects of insulin degludec on fasting plasma glucose and glycemic variability in individuals with type 2 diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes The change from baseline in
HbA1c after 24 weeks of treatment.

Standard deviation (SD) of fasting plasma glucose between 8- and 12-week or 20- and 24-week after treatment
Key secondary outcomes Frequencies of all hypoglycemic episodes
Frequencies of nocturnal hypoglycemic episodes during 0:01 and 5:59 AM
Plasma 1, 5 anhydro-D-glucitol
7 points plasma glucose (Daily profile)
Assessment of QOL evaluated by DTR-QOL
Dosage of insulin
Changes in body weight
Urinary 8 iso-prostane

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Insulin degludec arm
Starting dose 0.1U/Kg/Day
Once daily before breakfast
Duration: 24 weeks

Insulin titration: Treat to target (FPG less than 110 mg/dl)
Interventions/Control_2 Insulin glargine arm
Starting dose 0.1U/Kg/Day
Once daily before breakfast
Duration: 24 weeks

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes
Patients with insulin naive
Patients who have received oral anti-diabetic drugs more than 3 months
HbA1c values between 7.0 and 10.4%
Body mass index (BMI) less than 40.0
Patients who gave written informed consent
Key exclusion criteria Patients who have experienced severe diabetic ketosis, diabetic coma, or past history of pre-coma prior to 6 months
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 or glargine
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 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 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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
2013 Year 09 Month 20 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
2013 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 26 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 20 Day
Last modified on
2019 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013824


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