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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013244
Receipt No. 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

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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
Email 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
Email ykusu@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015454

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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