Cardiovascular and renal microvascular outcome study with linagliptin in patients with type 2 diabetes mellitus at high vascular risk

A multicenter, international, randomized, parallel group, double-blind, placebo-controlled, cardiovascular safety and renal microvascular outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk - CARMELINA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004148-23-PT

Enrollment

10790

Registered

2013-07-04

Start date

2013-10-04

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus type 2

Interventions

Trade Name: Trajenta Product Name: Linagliptin Product Code: BI1356 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LINAGLI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Documented diagnosis of T2DM before visit 1(screening). 2) Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if =>consecutive 7 days. 3) Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization. 4) HbA1c of => 6.5% and 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1 6) Body Mass Index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 2000

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes mellitus. 2) Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient. 3) Active liver disease or impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1. 4) eGFR <15 ml/min (severe renal impairment or ESRD, MDRD formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis. 5) Any previous (or planned within next 12 months) bariatric surgery (open or laparascopic) or intervention (gastric sleeve). 6) Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent

Design outcomes

Primary

Measure	Time frame
Main 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;Secondary Objective: If non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the composite renal endpoint will be investigated separately with a test on superiority; Primary end point(s): 1: Time to the first occurence of any of the following adjudicated components of the primary composite endpoint (4-point MACE): CV death, non-fatal MI, non fatal stroke and hospitalization for unstable angina pectoris ; Timepoint(s) of evaluation of this end point: 1: 48 months	—

Measure

Time frame

Main 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;Secondary Objective: If non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the composite renal endpoint will be investigated separately with a test on superiority; Primary end point(s): 1: Time to the first occurence of any of the following adjudicated components of the primary composite endpoint (4-point MACE): CV death, non-fatal MI, non fatal stroke and hospitalization for unstable angina pectoris ; Timepoint(s) of evaluation of this end point: 1: 48 months

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Secondary

Measure	Time frame
Secondary end point(s): 1: Time to first occurance of any of the following adjudicated components: CV death, non fatal MI and non fatal stroke (3-point MACE) 2: Time to first occurance of any of the following adjudicated composite renal endpoint: renal death, end stage renal disease and a sustained decrease of 50% or more in eGFR ; Timepoint(s) of evaluation of this end point: 1: 48 months 2: 48 months	—

Measure

Time frame

Secondary end point(s): 1: Time to first occurance of any of the following adjudicated components: CV death, non fatal MI and non fatal stroke (3-point MACE) 2: Time to first occurance of any of the following adjudicated composite renal endpoint: renal death, end stage renal disease and a sustained decrease of 50% or more in eGFR ; Timepoint(s) of evaluation of this end point: 1: 48 months 2: 48 months

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Countries

Argentina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Germany, Hungary, Israel, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+1800243 0127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026