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Regulatory post-marketing surveillance for Soliqua Pen Inj.(10-40), Soliqua Pen Inj.(30-60) in the treatment of type 2 diabetes mellitus

Regulatory post-marketing surveillance for Soliqua Pen Inj.(10-40), Soliqua Pen Inj.(30-60) in the treatment of type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009314
Enrollment
600
Registered
2024-04-05
Start date
2018-08-07
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, Bucheon St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: •male or female = 19 years old •Diagnosed type 2 diabetes mellitus • Patients who are scheduled to receive or have initiated the administration of SoliquaPen (10-40) and SoliquaPen (30-60) in accordance with the approved indications, based on the medical judgment of the investigator after the contract with the research institution • Patients who have understood the contents of the informed consent form for study participant data utilization, and voluntarily signed and dated the consent form.

Exclusion criteria

Exclusion criteria: • Patients treated with SoliquaPen (10-40) and SoliquaPen (30-60) outside the conditions of the approved indications in South Korea. • Patients who have previously used SoliquaPen (insulin glargine & lixisenatide) before the contract with the research institution. • Patients who were already using SoliquaPen (insulin glargine & lixisenatide) at the time of contract with the research institution. • Patients with contraindications to the treatment with SoliquaPen (10-40) and SoliquaPen (30-60) as specified in the approved indications: - Patients hypersensitive to the main ingredients or other components of this drug. - Patients with Type 1 diabetes or diabetic ketoacidosis. • Pregnant, lactating, or women planning to become pregnant.

Design outcomes

Primary

MeasureTime frame
Significant Adverse Events

Secondary

MeasureTime frame
• Glycosylated Hemoglobin Test (HbA1c(%));Fasting plasma glucose;2h-post prandial glucose;body weight

Countries

Korea, Republic of

Contacts

Public ContactSang Soo Kim

Pusan National University Hospital

drsskim7@gmail.com+82-70-1577-0675

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026