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Could a diabetes drug fix period problems in teens with type 1?

NCT ID NCT07319286

Disease control Sponsor: Ain Shams University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether dulaglutide, a drug used for type 2 diabetes, can help regulate menstrual cycles in adolescent girls with type 1 diabetes who have poor blood sugar control. Researchers will give some participants dulaglutide plus insulin, while others get only insulin. The goal is to see if the drug reduces irregular periods, such as missed or unpredictable cycles.

What this could mean

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

Active substance
Dulaglutide (a GLP-1 receptor agonist)
What this could lead to
If it works, this could point toward a new way to improve menstrual health in teens with type 1 diabetes.
What could go wrong
This is a small, early-phase study (50 participants) with no blinding. Results may not apply to all teens, and dulaglutide may cause side effects like nausea or gastrointestinal issues.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

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

12 to 18 years

Sex

Anyone

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: * Diagnosis of Type 1 Diabetes Mellitus according to ISPAD criteria * Use of continuous glucose monitoring (CGM) * Receiving regular insulin therapy * Regular follow-up at a diabetes clinic * Female participants aged 12 to 18 years * At least 2 years post-menarche * Poor glycemic control, defined as HbA1c ≥ 7% Exclusion Criteria: * Presence of medical conditions known to cause menstrual irregularities, including:(Connective tissue disorders, Autoimmune diseases, Clinical thyroid dysfunction, Neurological diseases). * History of severe hypoglycemia within the past 12 months * Other causes of abnormal uterine bleeding, including:(Structural causes (e.g., leiomyoma, endometrial polyp), Coagulation disorders, Ovulatory disorders (e.g., hyperprolactinemia, hyperandrogenism), Iatrogenic causes (e.g., steroid therapy, oral contraceptive use) * Family history of medullary thyroid carcinoma or multiple endocrine neoplasia History of pancreatitis

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Conditions

The condition(s) this trial relates to.

menstrual disorder Menstruation Disturbances type 1 diabetes mellitus

As listed by the trial registrant

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

Female reproductive health Glucagon-like peptide-1 receptor agonists Menstrual irregularities TYPE1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ain shams university

    Cairo, Cairo Governorate, 00202, Egypt

  • Ain shams university

    Cairo, Cairo Governorate, 11517, Egypt

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