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Insulin vs. pills: which is safer for gestational diabetes?

NCT ID NCT07582471

Disease control Sponsor: Dr Mudassar Saeed Pansota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared insulin injections and metformin pills in 60 pregnant women with gestational diabetes to see which is safer and more effective. Participants were randomly assigned to receive either insulin or metformin, and researchers monitored blood sugar levels and newborn health. The goal is to find the best treatment to prevent complications for both mother and baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insulin (Humulin R) and metformin
What this could lead to
If successful, this could help doctors choose the safer and more effective medication for managing gestational diabetes, reducing risks for both mother and baby.
What could go wrong
This is a small, completed study with only 60 participants, so results may not apply to all pregnant women. Both treatments have known risks, and the study does not guarantee long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Oct 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gestational diabetes Insulin Resistance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes mellitus (GDM)

Contacts and locations

Locations

  • Shahida Islam Teaching Hospital

    Lodhran, Punjab Province, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.