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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007203
Receipt No. R000008392
Scientific Title A clinical study of combination drug against type 2 diabetes - Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
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 combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
Acronym A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
Scientific Title A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
Scientific Title:Acronym A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
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 and safety of taking unblindedly Glubes combination tablets, combined with mitiglinide calcium hydrate and voglibose, for type 2 diabetes patients who had been taking inadequate glycemic control with a monotherapy of a-GI(voglibose, acarbose, or miglitol) or glinide(mitiglinide calcium hydrate, nateglinide) in addition to diet and exercise regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy endpoints:HbA1c(the JDS), blood glucose, glycated albumin, insulin, 1.5-AG, C-peptide, free fatty acids, triglycerides, apoB48, and apoC-3. Calculate HOMA-IR and HOMA-B in order to evaluate insulin resistance and function of pancreatic beta cell at each evaluation point.

Primary endpoints:HbA1c(the JDS) at the final evaluation point of each patient.
Compare the items of efficacy endpoints and the descriptive statistical number of the changing rate at each evaluation points, to the rate at 0week with t-test.
Calculate the 6.5% achievement ratio of HbA1c at each evaluation points.
Study the efficacy of taking a-GI or each glinide drugs which had been used before this study.

Safety endpoints:Evaluate the frequency and the occurrence of adverse events during this study.
Calculate the number of events and cases on the treatments of every 4 weeks, and calculate the total number of events and cases.
Analyze the adverse events against the drug by its grade, organ, and causal relationship.
Measure the descriptive statistics of observation period(0week) and treatment period(16th week) as laboratory evidences, and find the ratio of appearance of unusual change on each test values.
Measure the transitions of values of weights and blood pressures, on every 4 weeks of treatment periods.
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0th week: Perform examination under fasting conditions at the clinic. Perform examination again after the patients, who have signed a consent form, take an agent of a-GI or Glinide, and take a meal tolerance test
16th week: Perform examination under fasting conditions at the clinic. Perform examination again after the patients, who have signed a consent form, take the Glubes combination tablets and take a meal tolerance test
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 poorly controlled with the monotherapy of a-GI or glinide in addition to diet and exercise regimen, and regarded as appropriate to be treated with Glubes combination tablets.
2) Patients who have 6.5% HbA1c or more.
3) Age 20<=
4) Outpatient
5) Patients who voluntarily signed to the consent form with the 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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Sato
Organization Sato Internal medicine clinic
Division name M.D
Zip code
Address Nanpeidaichou13-1,Shibuya-ku,Tokyo Sato Bilding1F
TEL 042-352-7676
Email erika-yamagishi@npo-acro.jp

Public contact
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
2012 Year 01 Month 12 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=R000008392

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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