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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus, Type 2
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

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

Patient 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

Patient 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

To Learn more
Gender

Both Male and Female

Age

40 to 85 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Eastern Research
760 East 49th Street
Hialeah, FL 33013
Phone: 305-681-3111

View Map

Research Center Information: Eastern Research

CW ID: 180095

Date Last Changed: July 19, 2013


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