UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013244 |
|---|---|
| Receipt number | R000015454 |
| Scientific Title | Effects of miglitol on glucose metabolism and gut-derived hormones in type 2 diabetes who lose response to sitagliptin |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2016/02/24 17:00:24 |
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Basic information
Public title
Effects of miglitol on glucose metabolism and gut-derived hormones in type 2 diabetes who lose response to sitagliptin
Acronym
The beneficial effects of add-on therapy with miglitol in type 2 diabetes mellitus treated with sitagliptin
Scientific Title
Effects of miglitol on glucose metabolism and gut-derived hormones in type 2 diabetes who lose response to sitagliptin
Scientific Title:Acronym
The beneficial effects of add-on therapy with miglitol in type 2 diabetes mellitus treated with sitagliptin
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 analyze the beneficial effects of add-on therapy with miglitol, alpha-glucosidase inhibitor (alpha-GI) in sitagliptin, dipeptidyl peptidase-4 inhibitor (DPP-4I) treated Japanese type 2 diabetes mellitus (T2DM)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma glucose, HbA1c, GA, 1,5-AG,Peptide, active GLP-1, and body weight
Key secondary outcomes
QOL
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
Miglitol 150 mg/day
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetes mellitus
2. Patiens are receiving 50 mg/day of sitagliptin for more than three months
3. HbA1c has changed for the worse
4. HbA1c(NGSP) is less than 10.0% more than 6.9%
Key exclusion criteria
1. Patients with serious heart, liver, kidney diseases
2. Pregnant and/or breathbeeding, child-bearing potential women.
3. Patients who is complicated with a malignant tumor
4. Patients with severe infection, perioperative, severe injury
5. Patients who are undergoing treatment with an arufa-glucosidase inhibitor or a rapid-acting insulin secretagogue
6. Other patients whom their physicians in charge considered unsuitable for inclusion in this study
a. Patients who has laparotomy or ileus
b. Patients with chronic bowel diseases with malabsorption
c. Patients who has the disease which is deteriorated with increase of gas in bowel
d. Patients with intolerance in Lactose
e. Patient with diabetic retinopathy to need photocoagulation or vitreous surgery
f. Patients with serious diabetic complications including progressed neutopathy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kusunoki |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-45-6592
ykusu@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kusunoki |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology, and Metabolism, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-45-6592
Homepage URL
ykusu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of 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 | 03 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 24 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015454
