Investigating the Effect of Ryzodeg® in Adult Patients With Type 2 Diabetes in Lebanon

NCT ID: NCT04892069

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2021-11-18

Brief Summary

The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ryzodeg®

Participants are patients with Type 2 Diabetes (T2D) treated with Ryzodeg® (Insulin Degludec/Insulin Aspart) in a real-world adult population in Lebanon

Insulin Degludec/Insulin Aspart

Intervention Type: DRUG

All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. Decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Interventions

Insulin Degludec/Insulin Aspart

All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. Decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Male or female, age above or equal to 18 years at the time of signing the informed consent.
• Patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
• Patients who were not achieving optimal glycaemic control and who required intensification of antidiabetic treatment and Ryzodeg was the treatment of choice.
• Available and documented HbA1c value at less or equal to 12 weeks prior to initiation of Ryzodeg® treatment and end of study within the study windows.
• Available and documented follow up time of at least 52 weeks with 26 weeks follow-up prior to and after initiation of Ryzodeg®.
• The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Exclusion Criteria

• Previous participation in this study. Participation is defined as signed informed consent.
• Participation in any clinical study of an approved or non-approved investigational medicinal product within 26 weeks before and after initiation of treatment with Ryzodeg®.
• Having been previously treated with Ryzodeg® prior to study start.
• Female who were pregnant or breast-feeding during the study.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Beirut, Hamra, Beyrouth, Lebanon

Countries

Lebanon

Other Identifiers

U1111-1235-6983

Identifier Type: OTHER

Identifier Source: secondary_id

NN5401-4597

Identifier Type: -

Identifier Source: org_study_id