NN1250-4129 A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba® (insulin degludec) to evaluate long term safety and efficacy 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
• Medical condition to be studied:
  Type 1 diabetes mellitus

  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients with diabetes mellitus requiring insulin therapy who qualify for starting treatment with Tresiba® based on the clinical judgment by their treating physician during enrolment period.
• 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:
  1056

Study design details

• Main study objective:
  To assess the safety of long-term treatment with insulin degludec (Tresiba®) in insulin requiring patients with diabetes mellitus, initiating treatment with Tresiba® under routine clinical practice in India.
• Outcomes:
  Incidence of adverse events (AEs) by preferred term, - Incidence of serious adverse events (SAEs) by preferred term- Incidence of serious adverse drug reactions (SADRs) by preferred term- Incidence of adverse drug reactions (ADRs) by preferred term- Incidence of severe hypoglycaemia- Change from baseline in glycosylated haemoglobin (HbA1c)- Change from baseline in fasting plasma glucose (FPG)- Incidence of confirmed hypoglycaemia
• 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

4129-nsr-redacted