UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004246 |
|---|---|
| Receipt number | R000005054 |
| Scientific Title | The Step-Up-Trial by biphasic insulin analogues |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2011/03/22 17:20:27 |
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Basic information
Public title
The Step-Up-Trial by biphasic insulin analogues
Acronym
High-Mix Study
Scientific Title
The Step-Up-Trial by biphasic insulin analogues
Scientific Title:Acronym
High-Mix Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the improvement of HbA1c by treatment with insulin aspart-70 three times daily (TID) (including combination with insulin aspart-30) vs. insulin aspart-50 TID (including combination with insulin aspart-30) in type 2 diabetes patients on poor blood glucose control treated with TID insulin regimen (i.e. fast acting or biphasic insulin including fast acting).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c levels after 16 and 28 weeks from the beginning of treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Insulin aspart-70
three times daily injection
for 28 weeks
Interventions/Control_2
Insulin aspart-50
three times daily injection
for 28 weeks
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. A written consent form for participating in this study is submitted
2. Type 2 diabetic patients whose ages are more than 20 years old
3. Type 2 diabetic patients treated with three times daily (TID) insulin regimen (i.e. fast acting or biphasic insulin including fast acting) for 12 weeks or more
4. HbA1c >= 7.5%
5. BMI <=30kg/m2
6. Subjects who can conduct SMBG
Key exclusion criteria
1. Type 1 diabetic patients
2. Patients who are pregnant or likely to become pregnant
3. Patients with severe complications
4. Patients having difficulty with the drug compliance
5. Other patients determined to be inappropriate for participating in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhisa Komatsu |
Organization
Shinshu University Graduate School
Division name
Department of Aging Medicine and Geriatrics
Zip code
Address
Asahi 3-1-1 Matsumoto Nagano 390-8621
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teiji Takeda |
Organization
Shinshu University Graduate School
Division name
Department of Aging Medicine and Geriatrics
Zip code
Address
Asahi 3-1-1 Matsumoto Nagano 390-8621
TEL
Homepage URL
Sponsor or person
Institute
Shinshu University Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 21 | Day |
Last modified on
| 2011 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005054
