UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010518
Receipt number R000012300
Scientific Title Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment
Date of disclosure of the study information 2013/04/19
Last modified on 2020/10/29 13:33:45

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Basic information

Public title

Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment

Acronym

Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment

Scientific Title

Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment

Scientific Title:Acronym

Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare insulin glarugine and insulin degludec for efficancy in basal-bolus treatment in type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of glucose variability between two treatments by the Continuous Glucose Monitoring System (Frequency of nocturnal hypoglycemia by basal-bolus insulin treatment with glarugine and degludec)

Key secondary outcomes

1)Standard deviation of nocturnal blood glucose levels
2)Correlation between ability of insulin secretion and Bolus/ Basal insulin ratio
3)Correlation between ability of insulin secretion and the frequency of nocturnal hypoglycemia


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

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

Hospitalized patients with type 2 diabetes under Basal-Bolus insulin therapy with glargine will be enrolled. First CGMS for 72-h will be performed after fasting blood glucose are controlled to the range from 80mg/dl to 130mg/dl (First basal period). Then, Insulin glargine will be replaced to same dose decrutec without changing bolus insulin,and second CGMS will be performed.

Interventions/Control_2

Hospitalized patients with type 2 diabetes under Basal-Bolus insulin therapy with degludec will be enrolled. First CGMS for 72-h will be performed after fasting blood glucose are controlled to the range from 80mg/dl to 130mg/dl (First basal period). Then, Insulin decrutec will be replaced to same dose glargine without changing bolus insulin,and second CGMS will be performed.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes who meet the following conditions:
(1)Age: younger than 75 years old, elder than 20 years old
(2)recent HbA1c : less than 12.0%

Key exclusion criteria

Patients who falls under any of the following conditions shall be excluded:
(1)diabetic coma
(2)severe renal dysfunction (eGFR less than 30)
(3)unstable pre or proliferative diabetic retinopathy
(4)severe infection
(5)administered steroid drugs
(6)pregnant or planned pregnant in the near future
(7)ineligible for some other medical reasons judged by the investigator

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Kawashima

Organization

Naga Municipal Hospital

Division name

Department of Internal Medicine

Zip code

649-6414

Address

1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan

TEL

0736772019

Email

soumu@nagahp.jp


Public contact

Name of contact person

1st name Tetsushi
Middle name
Last name Nasu

Organization

Naga Municipal Hospital

Division name

Department of Internal Medicine

Zip code

649-6414

Address

1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan

TEL

0736772019

Homepage URL


Email

soumu@nagahp.jp


Sponsor or person

Institute

Naga Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Naga Municipal Hospital

Address

1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan

Tel

0736772019

Email

soumu@nagahp.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

公立那賀病院内科 Department of Internal Medicine, Naga Municipal Hospital


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 19 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

Terminated

Date of protocol fixation

2013 Year 04 Month 15 Day

Date of IRB

2013 Year 04 Month 16 Day

Anticipated trial start date

2013 Year 04 Month 19 Day

Last follow-up date

2013 Year 07 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

2013 Year 04 Month 17 Day

Last modified on

2020 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name