CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes - Full Text View

Purpose

The aim of the study is to investigate the longterm 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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: linagliptin Drug: glimepiride Drug: linagliptin placebo Drug: glimepride placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride Linagliptin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The time to the first occurence of any of the following adjudicated components of the primary composite endpoint: CV death, non-fatal MI, non-fatal stroke and hospitalisation for unstable angina pectoris at Week 400 (or FinalVisit) [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite endpoint of (proportion of pts on study treatment at study end, maintain glycemic control (HbA1c =< 7%) without need of rescue med and without moderate/severe hypoglycemic episodes and without => 2% weight gain at Week 400 (or Final Visit). [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
Composite endpoint of (proportion of patients on study treatment at study end, maintain glycemic control (HbA1c =< 7%) without need of rescue medication and without => 2% weight gain at Week 400 (or Final Visit). [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	6000
Study Start Date:	October 2010
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	September 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: linagliptin patient to receive linagliptin or glimepiride placebo overencapsulated tablet QD	Drug: linagliptin linagliptin tablets 5mg QD Drug: glimepride placebo glimepiride placebo
Active Comparator: glimepiride 1-4 mg QD patient to receive glimepiride 1-4 mg or linagliptin placebo tablet QD	Drug: glimepiride glimepiride over-encapsulated tablet 1-4 mg QD Drug: linagliptin placebo linagliptin placebo

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Type 2 diabetes
Elevated glycosylated heamoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor

Exclusion criteria:

Type 1 diabetes
Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243424

Show 614 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Eli Lilly and Company

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01243424 History of Changes
Other Study ID Numbers:	1218.74, 2009-013157-15
Study First Received:	November 17, 2010
Last Updated:	May 15, 2013
Health Authority:	Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Australia: Dept of Health and Ageing Therapeutic Goods Admin Belgium: Federal Agency for Medicinal and Health Products Brazil: National Health Surveillance Agency Bulgaria: Ministry of Health Canada: Health Canada Chile: Comision Nacional De Investigacion Cientifica y Tecnologica Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Georgia: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Greece: Ethics Committee Hong Kong: Department of Health Hungary: National Institute of Pharmacy India: Drugs Controller General of India Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ethics Committee Japan: Ministry of Health, Labor and Welfare Malaysia: Ministry of Health Mexico: Federal Commission for Protection Against Health Risks Netherlands: Central Committee Research Involving Human Subjects New Zealand: Medsafe Norway: Norwegian Medicines Agency Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Portugal: National Pharmacy and Medicines Institute Romania: Ministry of Public Health Russia: Pharmacological Committee, Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control South Africa: Medicines Control Council South Korea: Ministry of Food and Drug Safety (MFDS) Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Taiwan: Tunisia: Ministry of Public Health Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
BI 1356
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013