Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus

NCT07582471 | Completed DMC

• 1 other identifier: Shahida Islam hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

gestational diabetes mellitus; insulin; metformin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

insulin

EXPERIMENTAL

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)

oral hypoglycemic group

PLACEBO COMPARATOR

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

Interventions

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

insulin

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

oral hypoglycemic group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Mudassar Saeed Pansota: lead

Study Sites (1)

Shahida Islam Teaching Hospital

Lodhran, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• mudassar pansota

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: October 8, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

PA (1)