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

Ain Shams University

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Glucagon-Like Peptide-1 Receptor Agonists; Type1 Diabetes Mellitus; Menstrual Irregularities; Female Reproductive Health

Treatments: Drug: Dulaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT07319286

FMASU MD142/2025

Details and patient eligibility

About

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 .

Full description

All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups:

• Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy.
• Group 2: will only receive conventional insulin therapy. 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control

No Intervention group

Description:

All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: this group will only receive conventional insulin therapy.

dulaglutide GROUP

Active Comparator group

Description:

All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: • Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy.

Treatment:

Drug: Dulaglutide