A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. (CARMELINA)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial
• If ‘other’, further details on the scope of the study:
  Therapy/Efficacy
• Data collection methods:
  Primary data collection

Non-interventional study

No information provided.

Clinical trials

• Clinical trial regulatory scope:
  Post-authorisation interventional clinical trial
• Clinical trial phase:
  Therapeutic use (Phase IV)
• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LINAGLIPTIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients with Type 2 Diabetes Mellitus at High Vascular Risk.
• 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:
  Renal impaired
• Estimated number of subjects:
  7.000

Study design details

• Main study objective:
  The primary objective is to demonstrate non-inferiority of treatment with linagliptin in comparison with placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint in patients with type 2 diabetes mellitus.
• Outcomes:
  Time to the first occurence of any of the following by adjudication confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non fatal stroke. Time to the first occurance of any of the following by adjudication confirmed components: composite renal endpoint (renal death, sustained end stage renal disease, sustained decrease of 40% or more in eGFR).
• Data analysis plan:
  For the primary analyses a Cox proportional hazards regression model of time to first event with factor treatment and geographical region will be conducted. The primary analyses will be performed on the Treated Set following the intent-to-treat principle.