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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001891
Receipt No. R000002278
Scientific Title Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Date of disclosure of the study information 2009/04/15
Last modified on 2012/04/17

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Basic information
Public title Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Acronym Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Scientific Title Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Scientific Title:Acronym Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in 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 To compare glucose variability in patients given pioglitazone or metformin by using continuous glucose monitoring (CGM).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glucose variability in CGM (area under the glucose curve from pre-meal baseline to baseline, pattern of glucose curve, magnitude of increase in glucose levels and the time to peak glucose levels from baseline after each meal)
Key secondary outcomes Pre-meal plasma glucose, 2 hour post prandial glucose, side effect, body weight change

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 pioglitazone
Interventions/Control_2 metformin
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 Type 2 diabetic patients on no other antidiabetic medications (6.0=<HbA1c<10.0%, BMI>=25kg/m2)
Key exclusion criteria Patients with type 1 diabetes, patients with severe liver disease, patients with severe renal disease, patients with severe heart disease, patients with history of myocardial infarction within 6 months, patients with severe pancreatic disease, cancer patients, patients with severe diabetic neuropathy, patients with severe diabetic retinopathy, patients with history of lactic acidosis, heavy drinkers, pregnant patients
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aya Morimoto
Organization Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-25-8, Nishishinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Aya Morimoto
Organization Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-19-18, Nishisinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 15 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
2009 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 15 Day
Last modified on
2012 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002278

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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