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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010353
Receipt No. R000009797
Scientific Title An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
Date of disclosure of the study information 2014/03/28
Last modified on 2014/12/16

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Basic information
Public title An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
Acronym An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
Scientific Title An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
Scientific Title:Acronym An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To compare the pleiotropic effects including glucose metabolism on patients with type 2 Diabetes between Bolus First (insulin glulisine three times daily) and Basal First Insulin (insulin glargine at bedtime)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes M values
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Insulin glulisine was Administered before every meals.
Insulin dose is adjusted every day based on the results of blood glucose self-measurement.
Interventions/Control_2 insulin glargine was Administered before every sleeps. Initial insulin dose is calculated from the following equation.
Insulin dose is adjusted every day based on the results of blood glucose self-measurement.
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

Not applicable
Gender Male and Female
Key inclusion criteria The subjects must satisfy the following conditions:
1) An age at the time of obtaining informed consentis more than 20 years old
2) Patients with type 2 diabetes, whose HbA1c is more than 7.4%.
3) Gender is unquestioned:
4) Patients who are admitted to the purpose of glycemic control more than two weeks
Key exclusion criteria 1.Hypersensitivity to components of the insulin glargine and insulin glulisine.
2.None Type 2 diabetes
3.Medical history and/or complication of diabetic ketoacidosis.
4.Medical history and/or complication of severe hypoglycemia.
5.severe infection, around surgery or severe trauma.
6.Patients who received the administration of insulin, DPP-4 inhibitors or GLP-1 analog formulation within 4 weeks.
7.Treatment with glucocorticoid.
8.Uncontrolled Hypertension(systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
9.Proliferative retinopathy or maculopathy.
10.History of malignancy.
11.Severe health problems not suitable for the study.
12.Patients participated in other clinical trials within one month before the study.
13.Cases that Physicians deem inappropriate as the target of the test.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKAMURA Toshinari
Organization kanazawa University Graduate School of Medical Science.
Division name Department of Disease control and homeostasis
Zip code
Address 13-1 Takara-machi, kanazawa, Ishikawa, Japan
TEL 076-265-2234
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name TAKAMURA Toshinari
Organization kanazawa University Graduate School of Medical Science.
Division name kanazawa University Graduate School of Medical Science.
Zip code
Address 13-1 Takara-machi, kanazawa, Ishikawa
TEL 076-265-2234
Homepage URL
Email ttakamura@m-kanazawa.jp

Sponsor
Institute Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
Institute
Department

Funding Source
Organization Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
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
2014 Year 03 Month 28 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
2011 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 29 Day
Last modified on
2014 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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