NN5401-4149 A multi-centre, open-label, single-arm, non-interventional, post marketing sur-veillance (PMS) study of insulin degludec /insulin aspart in patients with diabetes mellitus in routine clinical practice in India

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 and secondary data collection

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

Documents

Study results

4149-nsr-redacted