UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005637 |
|---|---|
| Receipt number | R000006639 |
| Scientific Title | An Open Label Study Comparing the Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets |
| Date of disclosure of the study information | 2011/05/24 |
| Last modified on | 2012/03/21 14:12:18 |
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Basic information
Public title
An Open Label Study Comparing the Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets
Acronym
Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets
Scientific Title
An Open Label Study Comparing the Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets
Scientific Title:Acronym
Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets
Region
| Japan |
Condition
Condition
Type 2 diabetic mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the clinical equivalence between Generic Pioglitazone Hydrochloride 15mg (SAWAI) tablets and ACTOS Tablets 15 in type 2 diabetic patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change From Baseline in HbA1c at Week 12
Key secondary outcomes
Change From Baseline in Fasting Plasma Glucose at Week 12
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 | Maneuver |
Interventions/Control_1
Continue the same oral anti-diabetic drug and the diet/exercise regimen as the preceding 20 weeks for 4 weeks. At week 0, subjects were assigned to either Generic Pioglitazone Hydrochloride 15mg (SAWAI) tablets or ACTOS Tablets 15. Except for Pioglitazone Hydrochloride, the same treatments continue for another 12 weeks.
Interventions/Control_2
Continue the same oral anti-diabetic drug and the diet/exercise regimen as the preceding 20 weeks for 4 weeks. At week 0, subjects were assigned to either Generic Pioglitazone Hydrochloride 15mg (SAWAI) tablets or ACTOS Tablets 15. Except for Pioglitazone Hydrochloride, the same treatments continue for another 12 weeks.
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
Type 2 diabetic outpatients over 20 years of age.
Treated with 15 mg daily of ACTOS tablets 15 over 20 weeks prior to week -4.
Treated with single or double or triple oral hypoglycemic agent including ACTOS tablets 15 over 20 weeks prior to week -4.
HbA1c <=7.0% from the data week -4.
Written informed consent.
Key exclusion criteria
History and/or complication of cardiac failure.
Need of insulin therapy.
Treated using three or more oral anti-diabetes drugs other than ACTOS tablets 15.
Renal or liver dysfunction.
Complication with or recent history of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction.
Malignant neoplasms.
Severe ketosis, diabetic coma.
History of hypersensitive reaction to pioglitazone.
History of major gastrointestinal surgery.
Pregnancy.
History of alcohol abuse.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Fukushima |
Organization
Tokyo-Eki Center-building Clinic
Division name
Department of Internal Medicine
Zip code
Address
3-14, Nihonbashi 3-chome, Chuo-ku, Tokyo, 103-0027 JAPAN
TEL
03-3517-6688
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Fukushima |
Organization
Tokyo-Eki Center-building Clinic
Division name
Department of Internal Medicine
Zip code
Address
3-14, Nihonbashi 3-chome, Chuo-ku, Tokyo, 103-0027 JAPAN
TEL
03-3517-6688
Homepage URL
Sponsor or person
Institute
Tokyo-Eki Center-building Clinic
Institute
Department
Personal name
Funding Source
Organization
Tokyo-Eki Center-building Clinic
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
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
医療法人社団旭和会 東京駅センタービルクリニック（東京都）
財団法人柏市医療公社 柏市立柏病院（千葉県）
医療法人社団 阿佐谷クリニック（東京都）
芝パレスクリニック（東京都）
本田英比古クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 24 | 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
| 2010 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | 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
| 2011 | Year | 05 | Month | 24 | Day |
Last modified on
| 2012 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006639
