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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005393
Receipt No. R000006403
Scientific Title Comparision metformin and insulin for treatment of diabetes gestational
Date of disclosure of the study information 2011/04/09
Last modified on 2011/04/09

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Basic information
Public title Comparision metformin and insulin for treatment of diabetes gestational
Acronym Comparision metformin and insulin for treatment of diabetes gestational
Scientific Title Comparision metformin and insulin for treatment of diabetes gestational
Scientific Title:Acronym Comparision metformin and insulin for treatment of diabetes gestational
Region
South America

Condition
Condition Gestational diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism Obsterics and gynecology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Efficacy of metformin versus insulin for treatment of diabetes gestational
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Glycemic control
Weight gain

Key secondary outcomes Neonatal outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 metformin
Interventions/Control_2 insulin
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
17 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria Gestation only
Gestational diabetes without control by diet
Without malformations
Key exclusion criteria Noncompliance
Following the failure of patient
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Spaulonci, Cristiane P.
Organization Clinic Hospital (Sao Paulo University - Brazil)
Division name Obstetric Clinic
Zip code
Address Av. Dr Eneas de Carvalho, 255
TEL 55-11-30696209
Email

Public contact
Name of contact person
1st name
Middle name
Last name Rossana Pulcineli Vieira Francisco
Organization Clinic Hospital (USP - Brazil)
Division name Obstetric Clinic
Zip code
Address Av. Dr Eneas de Carvalho, 255
TEL 55-11-30696209
Homepage URL
Email crispavao@gmail.com

Sponsor
Institute Sao Paulo University - Brazil
Institute
Department

Funding Source
Organization self-funding
Organization
Division
Category of Funding Organization Outside Japan
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 Clinic Hospital (Sao Paulo University - Brazil)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 09 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 Open public recruiting
Date of protocol fixation
2007 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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 01 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 07 Day
Last modified on
2011 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006403

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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