UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001110 |
|---|---|
| Receipt number | 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 17:13:58 |
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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
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/
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001291
