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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007202
Receipt No. R000008374
Scientific Title A clinical study of a combination drug for type2 diabetes -Using self-monitoring of blood glucose and meal tolerance test-
Date of disclosure of the study information 2012/02/03
Last modified on 2013/09/27

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Basic information
Public title A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-
Acronym A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-
Scientific Title A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-
Scientific Title:Acronym A clinical study of a combination drug for type2 diabetes
-Using self-monitoring of blood glucose and meal tolerance test-
Region
Japan

Condition
Condition type2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study the efficacy of Glubes combination tablets in hyperglycemia and hyperlipidemia after a meal, using self-monitoring of blood glucose and meal tolerance tests after repetitive administrations of Glubes combination tablets and 10mg of Glufast in patients with type2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy endpoints:Blood glucose levels by SMBG. Amounts and changing value of blood glucose, insulin, proinsulin, C-peptide, glucagon, GLP-1, LDL-C, HDL-C, triglyceride, RLP-C, and free fatty acid after meal tolerance test, for each measurement point will be evaluated with descriptive statistics
Amounts and changing value of HbA1c, blood glucose, glycosylated albumin and 1.5-AG for each measurement point will be evaluated with descriptive statistics
Safety endpoints:The incident rate and the situation of side effects and adverse events during observation and treating periods.
Laboratory evidence is the use of descriptive statistics.
Key secondary outcomes

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 Check the blood glucose levels by self-monitoring nine times totally; three times in a day for observation period and administration period of Glufast or Glubes combination tablets.Take blood and urine sample and do a meal tolerance test at the clinic for each three period.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients only treated by diet and exercise therapy, or patients treated by oral hypoglycemic agents except SU or insulin who can have washout periods with those agents for more than four weeks
2) Possible to take the test meal (a set of Chicken in white sauce, crackers, soft pudding)
3) Over 20 years old
4) Voluntarily signed to the consent form after taking enough explanation of the significance and the objectives of this study
Key exclusion criteria 1) Patients who are applicable to the [taboo issue] in a package insert of Glubes combination tablets.
Patients who have severe ketosis, precoma or diabetic coma or type 1 diabetes.
Patients with severe infection or severe injury.
Patients accepting surgery.
Patients with a history of hypersensitivity to any component of this drug.
Pregnant women and women suspected to be pregnant.
2) Patients whom the principal investigator and investigators decided not to be appropriate for taking Glubes combination tablets, on the point of [Special caution needed] and [side effects] in the package insert.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuri Ono
Organization Yuri Ono Clinic Diabetes,Internal medicine
Division name M.D
Zip code
Address Sapporo Fukoku-Seimei-Ekimaedori Building 3F 1-17,Kita-2,Nishi-3,Chuo-Ku,sapporo,060-0002,Japan
TEL 011-223-5152
Email erika-yamagishi@npo-acro.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Erika Yamagishi
Organization NPO Advanced Clinical Research Organization
Division name NPO Advanced Clinical Research Organization
Zip code
Address 4F Hoei Fuchu Bulding,2-10-3 Kotobukicho,Fuchu-shi,Tokyo
TEL 042-352-7676
Homepage URL
Email erika-yamagishi@npo-acro.jp

Sponsor
Institute Advanced Clinical Research Organization
Institute
Department

Funding Source
Organization Advanced Clinical Research Organization
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
2012 Year 02 Month 03 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
2011 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 02 Day
Last modified on
2013 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008374

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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