CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01243424

Run by

Boehringer Ingelheim

People needed

6103

Starts

2010-11-11

Expected to finish

2018-08-21

Last updated by the study team

2020-01-07

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes
• Elevated glycosylated haemoglobin (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
• BMI =< 45kg/m²
• age between >= 40 and =< 85 years
• signed and dated written International Conference of Harmonisation( ICF)
• stable anti-diabetic background for at least 8 wks before study start

You may not qualify if…

• 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)
• treatment with any anti-obesity drug less than 3 months before ICF
• uncontrolled hyperglycemia
• previous or planned bariatric surgery or intervention
• current or planned system corticoid treatment
• change in thyroid hormones treatment
• acute liver disease or impaired hepatic function
• pre-planned coronary artery revascularization within 6 months of ICF
• known hypersensitivity to any of the components
• Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
• congestive heart failure class III or IV
• acute or chronic metabolic acidosis
• hereditary galactose intolerance
• alcohol or drug abuse
• participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start
• pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
• patients considered reliable by the investigator
• acute coronary syndrome =< 6 wks before ICF
• stroke or Transient Ischemic Attack (TIA) =< 3 months prior to ICF

Where it is running

• Alabama Internal Medicine, PC — Birmingham, Alabama, United States
• Cahaba Research, Inc. — Birmingham, Alabama, United States
• Internal Medicine Center, LLC — Mobile, Alabama, United States
• Diagnostic and Medical Clinic — Mobile, Alabama, United States
• Extended Arm Physicians, Inc. — Montgomery, Alabama, United States
• Office of Dr. Terence T. Hart MD — Tuscumbia, Alabama, United States
• Advanced Clinical Research — Pell City, Alaska, United States
• Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC — Mesa, Arizona, United States
• Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC — Mesa, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Quality of Life Medical & Research Center — Tucson, Arizona, United States
• Northeast Arkansas Baptist Clinic — Jonesboro, Arkansas, United States
• Medical Investigations, Inc — Little Rock, Arkansas, United States
• Aureus Research, Inc — Little Rock, Arkansas, United States
• Desert Oasis Healthcare — Bermuda Dunes, California, United States
• Edinger Medical Group and Research Center — Fountain Valley, California, United States
• Clinical Trials of St. Jude Heritage Med. Group — Fullerton, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Office of Dr. Richard S. Cherlin — Los Gatos, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Chaparral Medical Group, Inc — Pomona, California, United States
• ARI Clinical Trials, Inc — Redondo Beach, California, United States
• San Diego Sports Medicine and Family Health Center — San Diego, California, United States
• West Coast Research, LLC — San Ramon, California, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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