CAROLINA: Cardiovascular Outcome Study of Linagliptin versus Glimepiride in Patients with Type 2 Diabetes

The aim of the study is to investigate the long-term impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type-2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Official Title

A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type-2 Diabetes Mellitus at High Cardiovascular Risk.

Conditions

Diabetes Mellitus, Type-2

Study Type

Interventional

Study Design

Allocation: Randomised
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further Details

Primary Outcome Measures:

• Time to first occurrence of any of the following components of the primary composite endpoint: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina pectoris [ Designated as safety issue: No ]

 

Secondary Outcome Measures:

• Composite endpoint of (proportion of patients on study treatment at study end, maintain glycaemic control (HbA1c =< 7%) without need of rescue medication and without moderate/severe hypoglycaemic episodes and without => 2% weight gain at final visit [ Designated as safety issue: No ]
• Composite endpoint of (proportion of patients on study treatment at study end, maintain glycaemic control (HbA1c =< 7%) without need of rescue medication and without => 2% weight gain at final visit [ Designated as safety issue: No ]

Arms

Linagliptin: Experimental

Interventions

-Drug: Linagliptin

-Drug Glimepiride

 

Assigned Interventions

Linagliptin tablets, 5 mg QD

Glimepiride, overencapsulated tablet 1-4 mg

Study Start

October 2010 – September 2018

Eligibility & Criteria

Ages Eligible for Study: 40 Years to 85 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Total Enrolment

6000

Contact Details

clintriage.rdg@boehringer-ingelheim.com