UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013689 |
|---|---|
| Receipt number | R000015937 |
| Scientific Title | The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec. |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2016/04/11 12:03:47 |
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Basic information
Public title
The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec.
Acronym
The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec.
Scientific Title
The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec.
Scientific Title:Acronym
The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec.
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although both Single tablet of fixed dose mitiglinide and voglibose (M+V) and Linagliptine (L) can improve postprandial hyperglycemia, there are a few repot about the combination of basal insulin therapy and those oral hypoglycemic agents (OHAs).
In this study, we'll investigate the effect of combination therapy of the M+V or L with Insulin Degludec and also compare the effects for postprandial hyperglycemia after taking a test meal and a low carbohydrate meal.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Area Under the Curve of postprandial glucose levels after taking a test meal.
Key secondary outcomes
The Area Under the Curve of postprandial glucose levels after taking a low carbohydrate diet.
HbA1c, GA, and 1,5-AG.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Administration of single tablet of fixed dose mitiglinide (10 mg) and voglibose (0.2 mg) (three times a day) for 1-8 weeks and administration of linagliptin (5mg) (once a day) for 9-16 weeks with basal therapy of Insulin Degludec.
Interventions/Control_2
Administration of linagliptin (5mg) (once a day) for 1-8 weeks and administration of single tablet of fixed dose mitiglinide (10 mg) and voglibose (0.2 mg) (three times a day) for 9-16 weeks with basal therapy of Insulin Degludec.
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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients treated with insulin therapy and their HbA1c are less than 8.5%.
Key exclusion criteria
Patients with severe renal dysfunction, severe liver dysfunction, type 1diabetes, glutamic acid decarboxylase antibody positivity, malignancy, or other causes of hyperglycemia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Noda |
Organization
National Center for Global Health and Medicine
Division name
Depertment of Diabetes Research
Zip code
Address
1-21-1Toyama, Shinjukuku, Tokyo, Japan
TEL
03-3202-7181
mnoda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Ihana |
Organization
National Center for Global Health and Medicine
Division name
Depertment of Diabetes, Metabolism, and Endocrinology
Zip code
Address
1-21-1Toyama, Shinjukuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
nori_3373@yahoo.co.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 10 | 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
| 2014 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 11 | 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
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015937
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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