DelfaGLP-1 Atlas

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Enrolling by invitationPhase 1, PHASE2

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

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

50

estimated

Study population

Reproductive / infertility, Type 1 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Self-Reported Menstrual Irregularities

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07319286
Org study IDFMASU MD142/2025

Timeline

Milestones

Study start2025-08-04actual
Study first posted2026-01-06actual
Last update posted2026-01-27actual
Primary completion2026-04estimated (month precision)
Study completion2026-08estimated (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Reproductive / infertilityType 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Frequency of Self-Reported Menstrual Irregularities

Time frame:Baseline

categorical status, descriptive

Secondary/protocol endpoint

Frequency of Self-Reported Menstrual Irregularities

Time frame:Baseline to 3 months

Menstrual cyclicity

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Self-Reported Menstrual Cycle Length (days)

Time frame:Baseline to 3 months

Menstrual cyclicity

change from baseline, improvement

Other/protocol endpoint

Number of Participants Reporting Regular Menstrual Cycles

Time frame:3 months

Menstrual cyclicity

threshold achievement, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.