UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010282 |
|---|---|
| Receipt number | R000012031 |
| Scientific Title | Three-Arm Comparative Study of Miglitol and Mitiglinide Alone and in Combination -Efficacy and Safety Studies- |
| Date of disclosure of the study information | 2013/03/20 |
| Last modified on | 2013/03/20 08:06:52 |
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Basic information
Public title
Three-Arm Comparative Study of Miglitol and Mitiglinide Alone and in Combination
-Efficacy and Safety Studies-
Acronym
MM study
Scientific Title
Three-Arm Comparative Study of Miglitol and Mitiglinide Alone and in Combination
-Efficacy and Safety Studies-
Scientific Title:Acronym
MM study
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of miglitol and mitiglinide and the combination of both on the metabolic profile and
incretin secretion in Japanese type 2 diabetes patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic control
meal-loading tests:plasma glucose, serum insulin, total GLP-1, total GIP
HbA1c, 1,5-AG
Key secondary outcomes
high-molecular weight adiponectin, high sensitivity C reactive protein (hs-CRP),
8-Hydroxydeoxyguanosine(8-OhdG),
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Miglitol 150mg/day
Interventions/Control_2
Mitiglinide 30mg/day
Interventions/Control_3
Miglitol 150mg/day + Mitiglinide 30mg/day
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 with type 2 diabetes whose HbA1c (NGSP) was >= 6.5% but < 8.4% during prior treatment
(2)Patients who are undergoing dietary/exercise therapy or biguanide therapy in addition to dietary/exercise therapy
(3)Age >= 20 years
(4)Patients who have the ability to provide written informed consent personally
Key exclusion criteria
(1)Patients who have undergone dietary/exercise therapy of less than 8 weeks since diabetes diagnosis
(2)Patients who have undergone biguanide therapy of less than 8 weeks
(3)Patients who are undergoing treatment with a sulfonylurea agent
(4)Patients who are undergoing treatment with a thiazolidine agent
(5)Patients who are undergoing treatment with an arufa-glucosidase inhibitor
(Patients who had prior treatment with voglibose or acarbose were allowed to participate in this study, provided that 8 weeks or longer have passed since the termination of the oral treatment.)
(6)Patients who are undergoing treatment with a rapid-acting insulin secretagogue
(Patients who had prior treatment with nateglinide were allowed to participate in this study, provided that 8 weeks or longer have passed since the termination of the oral treatment.)
(7)Patients who are undergoing concomitant treatment with an arufa-glucosidase inhibitor and a rapid-acting insulin secretagogue
(8)Patients who are undergoing or who require insulin treatment
(9)Patients with severe ketosis or in a diabetic coma or pre-coma
(10)Patients with severe infection, perioperative, severe injury
(11)Patients with history of hypersensitivity to any ingredient in the study drug
(12)Women who are pregnant or who may be pregnant
(13)Other patients whom their physicians in charge considered unsuitable for inclusion in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Hashiramoto |
Organization
Kawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
+81-86-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Hashiramoto |
Organization
Kawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
+81-86-462-1111
Homepage URL
hashira@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Sanwa kagaku kenkyusho 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 20 | Day |
Last modified on
| 2013 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012031
