Home » Trials » SLCTR/2011/009
Treatment with a prefixed metformin regimen to reduce insulin requirements in Gestational Diabetes Mellitus
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SLCTR Registration Number
SLCTR/2011/009
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Treatment with a prefixed metformin regimen to reduce insulin requirements in Gestational Diabetes Mellitus
Public Title of Trial
Treatment with metformin to reduce insulin requirements in Diabetes in Pregnancy
Disease or Health Condition(s) Studied
Gestational diabetes mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
531/10 (Ethical review comittee, University of Sri Jayawardanepura)
What is the research question being addressed?
1.To assess the reduction of insulin requirement in women with gestational diabetes mellitus by using a prefixed Metformin dose of 500mg eight hourly
2.To compare the cost saving by reduction of insulin requirement ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Those who are diagnosed to be having GDM after 20 weeks of POG, needing additional treatment apart from diet and exercise will be recruited in to the study, depending on Blood Sugar Series valuesThe target values are preprandial value of 3.5–5.9 mmol and a 1 hour postprandial value of less than 7.8 mmol/litre They will be randomized using simple randomization into two groups Group 01- Metformin group - will be started on oral metformin 500mg eight hourly with 3 main meals Group 02-Insulin alone group For group 01, a repeat BSS will be done a week later and if further treatment needed insulin is added to achieve control For group 02, only insulin is used to achieve control. For both groups 2 weekly BSS will be done and insulin adjustments will be done accordingly to maintain fasting and postprandial venous blood sugar values within acceptable range
Inclusion criteria
Pregnant mothers who are diagnosed to be having GDM after 20 weeks needing additional treatment other than diet and exercise are recruited in to the study
Exclusion criteria
Those women with GDM before 20 weeks, Those with evidence of IUGR or hypertensive disease at the time of recruitment, Multiple pregnancies, Those who refuse consent for the study, Patients with elevated liver and renal function tests, will be excluded
Primary outcome(s)
|
1.
The reduction in insulin requirement per patient |
[ At the end of the study ] |
Secondary outcome(s)
|
1.
Cost reduction in treatment in GDM |
[ At the end of the study ] |
Target number/sample size
40 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2011-06-30
Anticipated end date
2012-06-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2011-05-26
Approval number
531/10
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Dhammika Silva
Senior lecturer
Department of Obstetrics and Gynaecology, University of Sri Jayawardanepura
011-2852695/96, 011-2801480
dammikesilva@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
