Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03648424
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Elisabetta Patorno, Brigham and Women's Hospital

Brief Summary:
This cohort study was initiated to predict the findings of CAROLINA trial in a real world setting using electronic claims data from insurance databases with results anticipated prior to the completion of CAROLINA.

Condition or disease
Type 2 Diabetes Mellitus

Detailed Description:

The CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA) is an ongoing randomized controlled trial (RCT) designed to assess whether linagliptin is non-inferior, and if so, superior compared with glimepiride 1-4 mg once daily with respect to cardiovascular (CV) events in adults with relatively early Type 2 Diabetes at increased risk of CV events and with less than optimized glycaemic control. Given that medications of both classes are currently advocated as second-line therapy after metformin, and since sulfonylureas have been associated with concerns regarding their CV safety, while dipeptidyl peptidase-4 inhibitors have been suggested to exhibit CV benefits in preclinical and mechanistic trials, the results of this trial will provide answers to several clinically relevant questions and have a significant impact on clinical practice.

This cohort study was initiated to predict the findings of CAROLINA trial in a real world setting using electronic claims data from insurance databases with results anticipated prior to the completion of CAROLINA. Trial eligibility criteria were adapted in claims data to generate a comparable study cohort (of linagliptin and glimepiride initiators) to that of the trial population. Using 1:1 propensity score-matching was used to control for >120 baseline characteristics. Patients were followed up for a composite cardiovascular outcome adapted from the primary end-point of the CAROLINA trial.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses
Actual Study Start Date : May 1, 2011
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Linagliptin
Patients who initiate Linagliptin with no use in the prior 180 days
Glimepiride
Patients who initiate Glimepiride with no use in the prior 180 days



Primary Outcome Measures :
  1. Composite Cardiovascular (CV) Outcome [ Time Frame: From treatment initiation to end of follow-up, up to 53 months ]
    Composite CV Outcome includes Myocardial infarction, Stroke, hospitalization for unstable angina and Death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients 40 - 85 years of age with early Type 2 Diabetes mellitus, increased cardiovascular risk or established complications
Criteria

Inclusion Criteria:

  • Patients with Type 2 diabetes who were new users of Linagliptin or new users of Glimepiride and:

    - Had no more than 3 anti-diabetic drugs including index drug

  • AND at elevated risk of cardiovascular (CV) events according to specific criteria:

    • Previous vascular disease
    • Evidence of vascular-related end-organ damage
    • Age ⩾ 70 years
    • ⩾ 2 CV risk factors:

      • Treated hypertension
      • Smoking
      • Using any lipid lowering treatment
  • Age ≥ 40 and ≤ 85 years at treatment initiation

Exclusion Criteria:

  • Patients with Type 1 Diabetes Mellitus
  • Previous exposure to dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, thiazolidinediones (TZDs), insulin or sodium glucose co-transporter-2 (SGLT-2s).
  • Exclude anti-diabetic background therapy if initiated in 2 months prior
  • Morbid obesity or treatment with anti-obesity drugs 3 months prior to treatment initiation
  • Severe hyperglycemia
  • Active liver disease or impaired hepatic function
  • Any previous bariatric surgery
  • Coronary artery re-vascularisation ≤ 6 weeks prior to treatment initiation
  • Prior hospitalization for congestive heart failure
  • Acute or chronic metabolic acidosis
  • Hereditary galactose intolerance
  • Alcohol or drug abuse within the 3 months prior to treatment initiation
  • Use of oral corticosteroids
  • Pregnant women
  • Patients with cancer
  • Acute coronary syndrome ≤ 6 weeks prior to treatment initiation
  • Stroke or Transient ischemic attack ≤ 3 months prior to treatment initiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648424


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Elisabetta Patorno, MD DrPH Brigham and Women's Hospital, Harvard Medical School

Layout table for additonal information
Responsible Party: Elisabetta Patorno, Assistant Professor of Medicine at Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03648424     History of Changes
Other Study ID Numbers: 2013P002157
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Elisabetta Patorno, Brigham and Women's Hospital:
Linagliptin
Cardiovascular Death
Stroke
Myocardial Infarction
Hospitalization for Unstable Angina
Type 2 diabetes mellitus
Glimepiride

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Linagliptin
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action