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

Phase 1

Conditions: Diabetes Mellitus type 2
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-004148-23-PT

Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 12280

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 <= 10.0% at Visit 1 (screening)
5) Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1
6) Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)
7) Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure
8) High risk of CV events

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br> 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<br> ;<br> Timepoint(s) of evaluation of this end point: 1: 48 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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)<br> <br> 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<br> ;<br> Timepoint(s) of evaluation of this end point: 1: 48 months<br> <br> 2: 48 months<br>

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