Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses
Completed
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03648424
- Run by
- Brigham and Women's Hospital
- People needed
- 48262
- Starts
- 2011-05-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2020-09-25
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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