NCT03841591

Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Completed Phase 3 Last updated 15 February 2019

What this trial tests

Phase 3 trial testing Insulin in Gestational Diabetes in 124 participants. Completed in 15 January 2019.

Timeline

1 February 2018

Primary endpoint
25 December 2018

15 January 2019

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	124
Start date	1 February 2018
Primary completion	25 December 2018
Estimated completion	15 January 2019
Sites	1 location across Egypt

Drugs / interventions tested

• Insulin (insulin) — full drug profile →
• Metformin (metformin) — full drug profile →
• Assessment of weight gain

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

Ain Shams University

Who can join

Adults 19 to 35, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.