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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004076
Receipt No. R000004908
Scientific Title Efficacy of miglitol on glycemic control in type 2 diabetes with insufficient basal insulin therapy
Date of disclosure of the study information 2010/08/21
Last modified on 2012/02/20

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Basic information
Public title Efficacy of miglitol on glycemic control in type 2 diabetes with insufficient basal insulin therapy
Acronym combination therapy of BOT and miglitol
Scientific Title Efficacy of miglitol on glycemic control in type 2 diabetes with insufficient basal insulin therapy
Scientific Title:Acronym combination therapy of BOT and miglitol
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficiency of miglitol on glycemic control (in paticular postprandial hyerglycemia) in type 2 diabetes patients with insufficient basal insulin therapy (BOT)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes efficacy of miglitol on glycemic control
(glycated hemoglobin and postprandial glucose values evaluated with meal loading test)
Key secondary outcomes effects of miglitol on inflammatory cytokines, adipocytokines, GLP-1, daily profile of blood glucose estimated by SMBG

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Addition of 150mg/day of miglitol on basal insulin therapy of optimal diet and exercise therapy. It is probibited to add other OAD and insulin during study period.
Interventions/Control_2 Continuation of optimaldiet and exercise therapy.It is probibited to add other OAD and insulin during study period.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)subjects whose HbA1c is 6.5-8.5%
(2)subjects whose fasting blood glucose is less than 120mg/dL
(3)subjects who recieved basal insulin and glimepiride therapy for more than 3 months
(4)subjcets whose age are more than 20 years.
(5)no restriction on gender
(6)subjects who chan understand informed consent
Key exclusion criteria 1) type 1 diabetes
2) patients who have serious liver disease (AST and/or ALT are more than 100IU/L)
3) patients who have serious kidney disease (Serum Cr is more than 2.0mg/dL)
4) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months)
5) patients who have serious pancreatic disease
6) patients with cancer
7) anemic patients (Hb is less than 11g/dL)
8) patients with thrombocytepenia (Platelet count is less than 100000/mm3)
9) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
10) patietns with serious infection, inflammation, or injuary. pre- or post- operative state
11) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ilus
12) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome
13) patients who has the disease which is deteriorated with increase of gas in bowel
14) patients who have histroy of gastrectomy
15) patients with intolerance in Lactose
16) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day)
17) patients who are pregnant, hope to be pregnant, or are in lactation period
18) patients who have viral infection (HBV,HCV)
19) patients who are not applicable to this study judged by the medical doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Hirose
Organization Juntendo University Graduate School of Medicine
Division name Dept of Medicine, Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Junetendo University Graduate School of Medicine
Division name Dept of Medicine, Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Email hirosemd@juntendo.ac.jp

Sponsor
Institute Dept of Medicine, Metabolisma and Endocrinology
Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Dept of Metabolism and Endocrinology
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 08 Month 21 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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 20 Day
Last modified on
2012 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004908

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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