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 identification

• EU PAS number:
  EUPAS4290
• Study ID:
  25218
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Brazil

  Bulgaria

  Canada

  Chile

  China

  Colombia

  Croatia

  Czechia

  Germany

  Hungary

  Israel

  Japan

  Korea, Republic of

  Malaysia

  Mexico

  Netherlands

  Poland

  Portugal

  Romania

  Russian Federation

  South Africa

  Spain

  Taiwan

  Ukraine

  United Kingdom

  United States
• Study description:
  CARMELINA is a randomized, double-blind, placebo controlled, parallel group study and compares treatment with linagliptin (5 mg once daily) to treatment with placebo (matching tablets once daily) as add-on therapy to standard of care
• Study status:
  Finalised

Research institutions and networks

Institutions

Dallas Diabetes and Endocrine Center

Multiple centres: 660 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:20/09/2012

Actual:20/09/2012

Study start date

Planned:31/07/2013

Actual:29/07/2013

Date of final study report

Planned:03/08/2018

Actual:08/08/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)