Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus

In order to ascertain the relative safety and effectiveness of insulin and OHAs in the treatment of GDM, well-designed, prospective clinical trials are required. GDM is growing more common, and proper care is crucial to preventing complications. Although the evidence is conflicting, both therapy approaches might be beneficial. To maximize outcomes for both mother and child, evidence-based recommendations for pregnant women with GDM must close this knowledge gap. Comparing the effects of insulin and metformin in gestational diabetes mellitus is the rationale for this study. We can thus give our people a medication with less fetal adverse effects based on these findings. Based on this empirical data, we can then incorporate some useful suggestions into our standard practice guidelines for the use of the more effective medication of the two for gestational diabetes mellitus in order to lower perinatal mortality and fetal morbidity.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shahida Islam Teaching Hospital

Lodhran, Punjab Province, Pakistan

About this study

A prevalent problem among pregnant women, gestational diabetes mellitus (GDM) typically manifests in the second and third trimesters. However, the reported frequency of GDM also varies globally due to variations in GDM diagnosis criteria. GDM raises the risk of harmful prenatal complications for both the mother and the fetus because of poorly managed blood glucose. Nonetheless, the application of more stringent criteria for the diagnosis of GDM (IADPSG criteria) is advised due to the recent advancements in our understanding of the condition, which will help with blood glucose control during pregnancy. Women are recommended to use diet and exercise to control their blood glucose levels after receiving a diagnosis of GDM. However, hypoglycemic medications like as insulin, metformin, glyburide, and in certain trials, acarbose, should be used for people who are unable to regulate their blood glucose.

When lifestyle changes are not successful, insulin has been the recommended treatment for GDM since it regulates blood glucose levels without passing through the placenta. The needs of each patient can be met by combining and matching formulations of short- and long-acting insulin. As treatments for GDM, oral hypoglycemic drugs such glyburide and metformin are becoming more and more well-liked. Metformin decreases the liver's production of glucose and increases insulin sensitivity, both of which result in lower blood glucose levels.6Gluburide encourages the pancreas to secrete more insulin. Despite being convenient and well-tolerated, there has been much debate and research over the safety and efficacy of oral administration during pregnancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Every woman with a cephalic presentation of singleton pregnancy (as determined by ultrasonography) with gestational diabetes mellitus.
A gestational age greater than 24 weeks (measured on LMP).
Age range: 18-45.
Parity 0-5

Exclusion criteria

Expectant mothers who already have chronic diabetes mellitus.
Women for whom oral hypoglycemics are contraindicated.
Underlying conditions such severe chronic hypertension, thyroid illness, chronic renal insufficiency, and hepatic disease that are known to impact fetal growth or medication clearance.
A history of insulin or metformin hypersensitivity

Treatment and study plan

Insulin (Humulin® R U-100)

Drug

those in group B will get insulin (Humulin R) subcutaneously whose dose can be adjusted within 24 hours according to blood sugar levels, whereas those in group A will receive 500 mg tablets of metformin twice daily orally

Oral Hypoglycemic Agents,Oral

Drug

For glycemic control and dosage modification, serum sugar levels will be checked on a regular basis. Blood glucose levels will be monitored after a fast, one hour after eating, and two hours after eating. Patients in which sugar cannot be controlled, then ward protocol can be followed for sugar control

Primary outcomes

percentage of neonatal hypoglycemia

Time frame: 24 hours

neonatal glucose values <30 mg/dl on two consecutive occasions within 24 hour of birth as measured by glucometer

Sponsors and collaborators

Lead sponsor

Dr Mudassar Saeed Pansota

Other

Registry information

Official study title

Comparison of the Outcome of Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 12, 2026
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed