Treatment with metformin to reduce insulin requirements in Diabetes in Pregnancy

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2011/009
• Date of registration: 24/06/2011
• Primary sponsor: None
• Public title: Treatment with metformin to reduce insulin requirements in Diabetes in Pregnancy
• Scientific title: Treatment with a prefixed metformin regimen to reduce insulin requirements in Gestational Diabetes Mellitus
• Date of first enrolment: 30/6/2011
• Target sample size: 40 in each arm
• Recruitment status: Pending
• URL: http://www.slctr.lk/trial_details.asp?reg_id={EB4782DB-4772-4792-B56B-A7C4DF0D9076}
• Study type: Interventional
• Study design: Prospective interventional Randomised control trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr Dhammike Silva
• Affiliation: Senior Lecturer

• Name: Dr Dhammike Silva
• Affiliation: Senior Lecturer

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Gestational diabetes mellitus

Intervention(s)

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

Primary Outcome(s)

The reduction in insulin requirement per patient

Secondary Outcome(s)

Cost reduction in treatment in GDM

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Nil