UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008369 |
|---|---|
| Receipt number | R000009834 |
| Scientific Title | An open label, randomized control study for the comparison of pleiotropic effects between Bolus First and Basal First insulin regimens on patients with type 2 diabetes |
| Date of disclosure of the study information | 2012/07/06 |
| Last modified on | 2020/04/05 21:07:43 |
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Basic information
Public title
An open label, randomized control study for the comparison of pleiotropic effects between Bolus First and Basal First insulin regimens on patients with type 2 diabetes
Acronym
An open label, randomized control study for the comparison of pleiotropic effects between Bolus First and Basal First insulin regimens on patients with type 2 diabetes
Scientific Title
An open label, randomized control study for the comparison of pleiotropic effects between Bolus First and Basal First insulin regimens on patients with type 2 diabetes
Scientific Title:Acronym
An open label, randomized control study for the comparison of pleiotropic effects between Bolus First and Basal First insulin regimens on patients with type 2 diabetes
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 pleiotropic effects including glucose metabolism on patients with type 2 Diabetes between Bolus First (insulin aspart three times daily) and Basal First Insulin (insulin detemir at bedtime)
Basic objectives2
Safety,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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
insulin aspart three times daily
Interventions/Control_2
insulin detemir at bedtime
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
1)Type 2 diabetes
2)HbA1c >=7.4%
Key exclusion criteria
1)Patients with allergies to insulin aspart or detemir
2)None type 2 diabetes
3)Medical history and/or complication of diabetic ketoacidosis
4)Medical history and/or complication of severe hypoglycemia
5)Treatment with insulin, DPP-4 inhibitor or GLP-1 analogue within 4 weeks prior to the study
6)Treatment with glucocorticoid
7)Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
8)Patients with proliferative retinopathy or maculopathy
9)Medical history and/or malignancy
10)Severe complications and problems not suitable for the study
11)Pregnant or lactating women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | TAKAMURA |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Disease Control and Homeostasis
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2234
ttakamura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | YUMIE |
| Middle name | |
| Last name | Takeshita |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Disease Control and Homeostasis
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2234
Homepage URL
takeshita@m-kanazawa.jp
Sponsor or person
Institute
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences
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
kanazawa university
Address
13-1 takaramachi
Tel
076-265-2049
t-isomu@adm.kanazawa-u.ac.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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
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
| 2010 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009834
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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