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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003830
Receipt No. 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

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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
Email 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
Email bleu-ciel@umin.ac.jp

Sponsor
Institute Chigasaki Municipal Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004617

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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