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Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07582471
Enrollment
60
Registered
2026-05-12
Start date
2025-10-08
Completion date
2026-04-07
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

gestational diabetes mellitus, insulin, metformin

Brief summary

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.

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.

Interventions

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

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

Sponsors

Dr Mudassar Saeed Pansota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of neonatal hypoglycemia24 hoursneonatal glucose values \<30 mg/dl on two consecutive occasions within 24 hour of birth as measured by glucometer

Countries

Pakistan

Contacts

STUDY_CHAIRmudassar pansota

Associate Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026