UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011827
Receipt number 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 12:51:05

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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


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



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 Yoshimasa
Middle name
Last name Aso

Organization

Dokkyo Medical University Hospital

Division name

Endocrinology and Metabolism

Zip code

321-0293

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 Kunihiro
Middle name
Last name Suzuki

Organization

Dokkyo Medical University Hospital

Division name

Endocrinology and Metabolism

Zip code

321-0293

Address

880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan

TEL

0282-86-1111

Homepage URL


Email

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

Dokkyo Medical University

Address

880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan

Tel

0282-86-1111

Email

yaso@dokkyomed.ac.jp


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

2013 Year 09 Month 25 Day

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013824


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name