Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1, phase 2) is built around Dulaglutide.

The aim of this study is to measure the frequency of menstrual irregularities among adolescent females with Type 1 diabetes mellitus and to assess the therapeutic effect of glucagon-like peptide-1 receptor agonist on menstrual irregularities in adolescent females with Type 1 diabetes mellitus .

It had two arms (groups): control (no intervention) and dulaglutide GROUP (active comparator).

The registry classes the interventions as drug.

More on the Plan

Dulaglutide is an FDA-approved drug in the U.S.; however, this study is conducted entirely outside the United States and is not under an FDA IND.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 12 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: 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; family history of medullary thyroid carcinoma or multiple endocrine neoplasia history of pancreatitis.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Nothing was hidden in this open-label Dulaglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-08-04 with completion listed for 2026-12.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Frequency of Self-Reported Menstrual Irregularities (time frame: Baseline).

It also tracked 1 secondary outcome, for example Frequency of Self-Reported Menstrual Irregularities.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Dulaglutide in 50 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.