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Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

40-85 years

Phase:

PHASE3

Brief Summary

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 hypoglycaem...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 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
  • 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)
  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 11 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 21 2018

    Estimated Enrollment :

    6103 Patients enrolled

    Trial Details

    Trial ID

    NCT01243424

    Start Date

    November 11 2010

    End Date

    August 21 2018

    Last Update

    January 7 2020

    Active Locations (613)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 154 (613 locations)

    1

    North Alabama Research Center, LLC

    Athens, Alabama, United States, 35611

    2

    Alabama Internal Medicine, PC

    Birmingham, Alabama, United States, 35235

    3

    Cahaba Research, Inc.

    Birmingham, Alabama, United States, 35242

    4

    Internal Medicine Center, LLC

    Mobile, Alabama, United States, 36608