UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005393 |
|---|---|
| Receipt number | 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 04:54:16 |
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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 | Obstetrics 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
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
crispavao@gmail.com
Sponsor or person
Institute
Sao Paulo University - Brazil
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006403
