UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012302 |
|---|---|
| Receipt number | R000014387 |
| Scientific Title | The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes. |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2013/11/15 05:33:48 |
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Basic information
Public title
The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Acronym
The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Scientific Title
The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 diabetes.
Scientific Title:Acronym
The effects of rapid acting insulin on glucose control in basal-bolus insulin treated type2 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 assess the efficacy of drugs using markers for glucose metabolism
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the value of makers for glycemic control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug administration
Interventions/Control_2
Drug administration
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients medicated with insulin Aspart
2. HbA1c value 7.0%-11%, type 2 diabetic patients
Key exclusion criteria
1) Patients with hypersensitivity to insulin Aspart and/or Lispro.
2) Patients with surgical operation, trauma or infection.
3) Patients who are pregnant
4) Patients with severe renal or liver failure
5) Patients with pituitary insufficiency or adrenal insufficiency.
6) Patients with diarrhea or vomit
7) Patients with heavy exercise
8) Juged as ineligible by clinical investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaya Matsushita |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Diabetology, Endocrinology and Metabolism
Zip code
Address
1163 Tate-machi, Hachioji, Tokyo, 193-0998, Japan
TEL
042-665-5611
tmatsush@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Matsushita |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Diabetology, Endocrinology and Metabolism
Zip code
Address
1163 Tate-machi, Hachioji, Tokyo, 193-0998, Japan
TEL
042-665-5611
Homepage URL
tmatsush@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hachioji Medical Center
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
東京医科大学八王子医療センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 20 | 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
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2013 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014387
