UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010353 |
|---|---|
| Receipt number | 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 13:55:06 |
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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
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
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009797
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| Registered date | File name |
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| Registered date | File name |
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