Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

INSULIN DEGLUDEC
INSULIN ASPART

Medical condition to be studied

Diabetes mellitus
Type 1 diabetes mellitus
Type 2 diabetes mellitus
Population studied

Short description of the study population

Patients with insulin requiring diabetes mellitus and who were scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Type 1&2 diabetes mellitus patients

Estimated number of subjects

1029
Study design details

Main study objective

To assess the safety of long-term treatment with insulin degludec/ insulin aspart (Ryzodeg™) in insulin requiring patients with diabetes mellitus, initiating treatment with Ryzodeg™ under routine clinical practice in India.

Outcomes

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs)Serious Adverse Drug Reactions (SADRs) Adverse Drug Reactions (ADRs) Severe or Blood glucose(BG) Confirmed hypoglycaemia Change in HbA1c (glycosylated haemoglobin)Change in Fasting Plasma Glucose (FPG)Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPGThe reason for initiating or intensifying treatment with Ryzodeg™

Data analysis plan

No formal statistical testing will be done in this non-interventional trial.All continuous and categorical endpoints will be analysed using descriptive statistics