Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus

Comparison of the Outcome of 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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Drug: Insulin (Humulin® R U-100); Drug: Oral Hypoglycemic Agents,Oral

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lodhran, Punjab Province, Pakistan
      • Shahida Islam Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: insulin; 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	Drug: Insulin (Humulin® R U-100); 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
Placebo Comparator: oral hypoglycemic group; 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	Drug: Oral Hypoglycemic Agents,Oral; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of neonatal hypoglycemia	neonatal glucose values <30 mg/dl on two consecutive occasions within 24 hour of birth as measured by glucometer	24 hours

Collaborators and Investigators

• Sponsor: Dr Mudassar Saeed Pansota
• Investigators: Study Chair: mudassar pansota, Associate Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Actual): April 7, 2026
• Study Completion (Actual): April 7, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: insulin; metformin; gestational diabetes mellitus
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes, Gestational; Insulin Resistance; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Proinsulin; Insulin
• Other Study ID Numbers: Shahida Islam hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No