UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019833 |
|---|---|
| Receipt number | R000022728 |
| Scientific Title | Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2017/05/22 08:49:13 |
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Basic information
Public title
Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
Acronym
Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
Scientific Title
Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
Scientific Title:Acronym
Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
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 background characteristics of type 2 diabetes mellitus patients that provide an advantage to switch the additional insulin of intensive insulin therapy after the resolution of glucose toxicity to mitiglinide calcium hydrate tablets or mitiglinide calcium hydrate/voglibose combination tablets. The efficacy of mitiglinide calcium hydrate tablets as well as mitiglinide calcium hydrate/voglibose combination tablets on basal insulin use is also studied.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Mean amplitude of glycemic excursions (MAGE)
2) Mean blood glucose level
3) Standard deviation (SD) of blood glucose level
4) Rate of glucose level AUC>=180 mg/dL, 70 mg/dL<AUC<180 mg/dL, and <70 mg/dL
5) Maximum and minimum blood glucose levels
6) Incidence of symptomatic hypoglycemia
7) Rate of glucose level <70 mg/dL
8) Blood glucose levels 1 and 2 h after every meal
9) Age, duration of diabetes, urinary CPR, 75g oral glucose tolerance test results (blood glucose, blood insulin, and blood CPR levels before the load, and 30 min, 1 hour and 2 hours after the load), glucagon stimulation test results (blood glucose, blood insulin, and blood CPR levels before and after the load), and the daily dose of additional insulin, the daily dose of basal insulin and the daily dose of total insulin at the time of informed consent
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After receiving mitiglinide for two days, patients receive mitiglinide / voglibose combination tablets for two days.
Interventions/Control_2
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 mellitus patients who are receiving intensive insulin therapy
2) Age >=20 years at the time of obtaining consent
3) Hospitalized patients
4) Patients whose glucose toxicity had resolved as judged by the investigator or sub-investigator (e.g., blood glucose level <150 mg/dL at 4 time points throughout a day; namely, before breakfast, before lunch, before dinner, and before going to bed)
5) Patients who are receiving <20 units/day of additional insulin
6) Patients who provided written consent
Key exclusion criteria
1) Patients who are taking other antidiabetes agents than insulin
2) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combination tablets based on their package inserts
3) Patients who were judged to be ineligible by the investigator or sub-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Nakamura |
Organization
Aichi Medical University
Division name
Division of Diabetes
Zip code
Address
1-1 Yazakokarimata Nagakute-shi Aichi-ken
TEL
0561-63-1683
jiro@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Kamiya |
Organization
Aichi Medical University
Division name
Division of Diabetes
Zip code
Address
1-1 Yazakokarimata Nagakute-shi Aichi-ken
TEL
0561-63-1683
Homepage URL
hkamiya@aichi-med-u.ac.jp
Sponsor or person
Institute
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
愛知医科大学病院 Aichi Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 18 | 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
| 2015 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022728
