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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001110
Receipt No. R000001291
Scientific Title Clinical study of combinational therapy of AD-4833 with metformin -Phase III double-blind comparative study-
Date of disclosure of the study information 2008/04/04
Last modified on 2010/08/27

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Basic information
Public title Clinical study of combinational therapy of AD-4833 with metformin
-Phase III double-blind comparative study-
Acronym Clinical study of combinational therapy of AD-4833 with metformin
Scientific Title Clinical study of combinational therapy of AD-4833 with metformin
-Phase III double-blind comparative study-
Scientific Title:Acronym Clinical study of combinational therapy of AD-4833 with metformin
Region
Japan

Condition
Condition Type2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the safety and efficacy of pioglitazone 30mg given once daily as combination therapy with metformin compared to placebo in combination with metformin in patient with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in HbA1C at the end of the treatment period
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 [Metformin]
Metformin is orally administered at fixed doses throughout the baseline observation period and the treatment period.
[AD-4833]
In Period I, one AD-4833 15 mg tablet is orally administered once daily before or after breakfast for 12 weeks. When there is no tolerability problem after 12 weeks of the treatment period, the study proceed to Period II, and one AD-4833 30 mg tablet is administered once daily before or after breakfast for 16 weeks. When there is any tolerability problem, the same study medication as in Period I is continued through the end of Period II or the medication is discontinued, depending on the degree of the problem.
Interventions/Control_2 [Metformin]
Metformin is orally administered at fixed doses throughout the baseline observation period and the treatment period.
[AD-4833]
In Period I, one AD-4833 placebo tablet is orally administered once daily before or after breakfast for 12 weeks. When there is no tolerability problem after 12 weeks of the treatment period, the study proceed to Period II, and one AD-4833 placebo tablet is administered once daily before or after breakfast for 16 weeks. When there is any tolerability problem, the same study medication as in Period I is continued through the end of Period II or the medication is discontinued, depending on the degree of the problem.
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Type 2 diabetes who are on medication with certain usage and dosage of Metformin (500mg or 750mg/day) during run-in period
(2) Type 2 diabetes who practise certain diet therapy during run-in period
(3) Type 2 diabetes whose HbA1C are over 6.5 % and under 10.0% after 8-week run-in period
Key exclusion criteria (1)Type 1 diabetes
(2)Those who have used different medication for diabetes from metformin-alone (including insulin) period,or have changed the diet therapy and exercise therapy during run-in period
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Kaku
Organization Kawasaki Medical School
Division name Diabetes and Endocrine Division, Department of Medicine
Zip code
Address 577 Matsushima Kurashiki-shi, Okayama,Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Takeda Pharmaceutical Company Limited
Division name Contact for Clinical Trial Infomation
Zip code
Address
TEL
Homepage URL https://www.takeda.co.jp/contact/form/jp/form/
Email

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2008 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.takeda.com/c-t/report-summaries/article_53.html
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
2005 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2006 Year 09 Month 01 Day
Date of closure to data entry
2006 Year 10 Month 01 Day
Date trial data considered complete
2006 Year 10 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 04 Day
Last modified on
2010 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001291

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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