UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012459
Receipt number R000014583
Scientific Title Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia
Date of disclosure of the study information 2013/12/02
Last modified on 2013/12/02 15:47:20

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Basic information

Public title

Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia

Acronym

Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec

Scientific Title

Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia

Scientific Title:Acronym

Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy and safety of switching from existing long-acting insulin to insulin degludec on outpatient practice.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of HbA1c levels after 12 weeks from baseline, achievement rate of HbA1c <7.0% and frequency of hypoglycemia in observation period.

Key secondary outcomes

1)Frequency of blood glucose level is 70mg/dL or lower at self-monitoring of blood glucose (SMBG) conducted 6 times a day within 2 weeks of switching 2)Standard deviation (SD) of blood glucose and intraindividual variability (CV%) at SMBG before breakfast 3)Change of glycoalbumin (GA) level and 1.5AG level in 24 weeks from baseline 4)Study of background factors in cases of attainment and non-attainment of HbA1c <7.0% 5)Change of insulin dosage 6)Changes of DTSQs, DTSQc 7)Changes of weight, BMI


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec

Interventions/Control_2


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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who have received insulin therapy including once-daily-administration of long-acting insulin for more than 12 weeks in addition to diet therapy and exercise therapy, and also fits the following requirement 1)HbA1c>=7.0% 2)Age between 20-80, regardless of sex

Key exclusion criteria

1)Patients who take long-acting insulin twice daily 2)Patients in contraindication of degludec 3)Patients who were considered not to be appropriate for administration of degludec by their doctors. 4)Patients who take high dosage of sulfonylurea drug: 3mg or more Glimepiride a day, 5mg or more Glibenclamide a day, 80mg or more Gliclazide a day. 5)Patients who take GLP-1 receptor agonist in combination

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masato Odawara

Organization

Tokyo Medical University

Division name

The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)

Zip code


Address

Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Email

naika3@tokyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Tamaru

Organization

Tokyo Medical University

Division name

The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)

Zip code


Address

Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Homepage URL


Email

naika3@tokyo-med.ac.jp


Sponsor or person

Institute

The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism),Tokyo Medical University

Organization

Division

Category of Funding Organization

Self funding

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 12 Month 02 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

Preinitiation

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 02 Day

Last modified on

2013 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014583


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name