NN1250-4189 A multi-centre, prospective, non-interventional study of insulin degludec investigating the safety and effectiveness in a real world population with type 1 and 2 diabetes mellitus (ReFLeCT)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary 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:
  Diabetes mellitus

  Type 1 diabetes mellitus

  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Male or female patients aged ≥18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  1262

Study design details

• Main study objective:
  The primary objective is to monitor and assess the safety of Tresiba®, used with any other anti diabetic treatment and according to label, by analysing whether treatment with Tresiba® OD is associated with a change in the rate of any hypoglycaemic episodes occurring during the observation period, compared to the rate of any hypoglycaemic episodes occurring during the baseline period.
• Outcomes:
  Change in the number of any hypoglycaemic episodes, Change from baseline in HbA1c (glycosylated haemoglobin)Change from baseline in FPG (Fasting Plasma Glucose)Change from the baseline period in the number of severe hypoglycaemic episodesChange from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))
• Data analysis plan:
  All observational endpoints will be analysed on the full analysis set (FAS). The FAS includes all patients who received at least 1 dose of Tresiba® at visit 2. Patients who complete visit 1 but do not initiate Tresiba® at visit 2 will be excluded from the analysis.Patients will be analysed separately based on being T1DM or T2DM patients treated with insulin.

Documents

Study results

4189-nsr-eu-pas-reg-redacted