UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009502 |
|---|---|
| Receipt number | R000011163 |
| Scientific Title | Effects of miglitol versus sitagliptin on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2012/12/07 |
| Last modified on | 2013/12/09 09:54:29 |
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Basic information
Public title
Effects of miglitol versus sitagliptin on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus
Acronym
Effects of miglitol versus sitagliptin on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus
Scientific Title
Effects of miglitol versus sitagliptin on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effects of miglitol versus sitagliptin on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to compare the effects of miglitol and sitagliptin, on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the vlaues (glucose, insulin, glucagon, NEFA, triglyceride, Apolipoprotein B48, RLP-C) by cookie loading test at baseline and 10 weeks after each treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
miglitol 150mg/day
Interventions/Control_2
sitagliptin 50mg/day
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
HbA1c<9.4%
Key exclusion criteria
-diabetic coma within 6 month before
-acute illness
-pregnancy
-renal dysfunction(creatinine: men>1.5mg/dL, women>1.3mg/dL)
-recent insulin therapy
-drug allergy
-anemia(hemoglobin: men<11g/dL, women<10g/dL)
-patient who disagree with this protocol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenta Okada |
Organization
Jichi Medical University
Division name
Division of Endocrinology and Metabolism
Zip code
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL
0285-58-7355
kokada@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Okada |
Organization
Jichi Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
3311-1 Yakushiji Shimotsuke-City Tochigi
TEL
0285-58-7355
Homepage URL
kokada@jichi.ac.jp
Sponsor or person
Institute
Division of Endocrinology and Metabolism, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Joint Research Association for Japanese Diabetes
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
| 2012 | Year | 12 | Month | 07 | 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
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 | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 07 | Day |
Last modified on
| 2013 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011163
