Status:
COMPLETED
Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
1029 Patients enrolled
Trial Details
Trial ID
NCT02230618
Start Date
November 24 2015
End Date
June 1 2017
Last Update
March 13 2018
Active Locations (35)
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1
Novo Nordisk Investigational Site
Guntur, Andhra Pradesh, India, 522001
2
Novo Nordisk Investigational Site
Vijayawada, Andhra Pradesh, India, 520002
3
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530002
4
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380007