UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022094
Receipt number R000025473
Scientific Title Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study
Date of disclosure of the study information 2016/05/02
Last modified on 2017/12/21 09:05:10

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Basic information

Public title

Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study

Acronym

Comparison of Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS using CGM

Scientific Title

Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study

Scientific Title:Acronym

Comparison of Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS using CGM

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 the effect between morning Insulin Glulisine + Insulin glargine 300 U/ml and morning Insulin lispro + Insulin glargine BS

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

CGM
M-value(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00)
MAGE
MODD
mean glucose level(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00)
SD(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00)
Preprandial glucose level
Highest postprandial glucose level within 3 hours after each meal
Time from start of meal to the highest postprandial glucose level
Differences between preprandial and highest postprandial glucose level for each meal
post-breakfast glucose gradient
AUC (over 180 mg/dL) for glycemic variability within 3 h of each meal
AUC (over 0 mg/dL) for glycemic variability in 24 h
AOC (under 70 mg/dL) for glycemic variability, mg.min/dL(24:00, 8:00-12:00, 0:00-8:00)

Key secondary outcomes



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

CGM is attached after admission. Insulin Glulisine + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, therapy is swhiched to Insulin lispro + Insulin glargine biosimilar on day 3 and day 4.

Interventions/Control_2

CGM is attached after admission. Insulin lispro + Insulin glargine are used on day 1 and day 2. Then, therapy is swhiched to biosimilarInsulin Glulisine + Insulin glargine 300 U/ml on day 3 and day 4.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

type 2 diabetic patients medicated basal insulin therapy for 3 month or longer

Key exclusion criteria

severe renal dysfunction (serum creatinine level over 2.0 mg/dL)
judged to be unsuitable for participation for medical reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeishi Soichi

Organization

General Inuyamachuo Hospital

Division name

Department of Diabetes

Zip code


Address

6, futakozuka, goroumaru, Inuyama-city, Aichi

TEL

0568-62-8111

Email

souichi19811225@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeishi Soichi

Organization

General Inuyamachuo Hospital

Division name

Department of Diabetes

Zip code


Address

6, futakozuka, goroumaru, Inuyama-city, Aichi

TEL

0568-62-8111

Homepage URL


Email

souichi19811225@yahoo.co.jp


Sponsor or person

Institute

General Inuyamachuo Hospital
Department of Diabetes

Institute

Department

Personal name



Funding Source

Organization

General Inuyamachuo Hospital

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

2016 Year 05 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

Completed

Date of protocol fixation

2016 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2016 Year 05 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

2016 Year 04 Month 27 Day

Last modified on

2017 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025473


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name