Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec/insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT02230618

NN5401-4149

U1111-1157-0615 (Other Identifier)

ENCEPP/SDPP/6587 (Registry Identifier)

Details and patient eligibility

About

This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.

Enrollment: 1,029 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
• Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician

Exclusion criteria

• Known or suspected allergy to Ryzodeg™ any of the active substances or any of the excipients
• Previous participation in this study
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Patients who are or have previously been on Ryzodeg™ therapy
• Patients who are participating in other studies or clinical trials
• Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months

Trial design

1,029 participants in 1 patient group

Ryzodeg™

Treatment:

Drug: insulin degludec/insulin aspart