UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003830 |
|---|---|
| Receipt number | R000004617 |
| Scientific Title | Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2013/12/31 13:23:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes
Acronym
Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes
Scientific Title
Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes
Scientific Title:Acronym
Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized controlled study was to evaluate the safety and efficacy of pioglitazone compare to metformin in glycemic control, insulin dose requirements, lipid profile and nephropathy in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of HbA1c from the baseline to 24 weeks later
Key secondary outcomes
body weight change,
fasting plasma glucose,
postprandial plasma glucose,
insulin dose requirements,
lipid profile(Total cholesterol,Triglyceride,LDL-cholesterol,HDL-cholesterol),
albuminuria,
Cystatin C,
High sensitivity CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 |
Interventions/Control_1
Insulin + Pioglitazone
(pioglitazone was started with 15mg/day and titrated up to 30mg/day)
Interventions/Control_2
Insulin + Metformin
(metformin was started with 500mg/day and titrated up to 2250mg/day)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) A consent form for participating in this study is submitted
2) Patients with type 2 diabetes
3) Patients treated with insulin therapy
4) HbA1c >= 7.5%
5) BMI<35kg/m2
Key exclusion criteria
1) Patients with type 1 diabetes
2) Patients receiving thiazolidiones or biguanides
3) Heart failure defined as NYHA class III or above
4) Having allergy to thiazolidiones or biguanides
5) Patients with severe liver failure or renal failure
6) History of acute coronary syndrome or cerebrovascular accident with in 3 months
7) Pregnant or breastfeeding
8) Patients with familial hypercholesterolemia
9) Other patients determined to be inappropriate by physician
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinobu Satoh |
Organization
Chigasaki Municipal Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-15-1 Honson Chigasaki-shi Kanagawa, Japan
TEL
0467-52-1111
shinobu@medical.email.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kondo |
Organization
Chigasaki Municipal Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
5-15-1 Honson Chigasaki-shi Kanagawa, Japan
TEL
0467-52-1111
Homepage URL
bleu-ciel@umin.ac.jp
Sponsor or person
Institute
Chigasaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
茅ヶ崎市立病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 04 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 27 | Day |
Last modified on
| 2013 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004617
