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

• Status: Completed
• Trial end date: 2018-08-21
• Target enrollment: 0
• Participant gender: All

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 hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Glimepiride; Linagliptin

Criteria

Inclusion criteria:

1. Type 2 diabetes

2. 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)

3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor

4. BMI =< 45kg/m²

5. age between >= 40 and =< 85 years

6. signed and dated written International Conference of Harmonisation( ICF)

7. stable anti-diabetic background for at least 8 wks before study start

Exclusion criteria:

1. Type 1 diabetes

2. 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)

3. treatment with any anti-obesity drug less than 3 months before ICF

4. uncontrolled hyperglycemia

5. previous or planned bariatric surgery or intervention

6. current or planned system corticoid treatment

7. change in thyroid hormones treatment

8. acute liver disease or impaired hepatic function

9. pre-planned coronary artery revascularization within 6 months of ICF

10. known hypersensitivity to any of the components

11. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information

12. congestive heart failure class III or IV

13. acute or chronic metabolic acidosis

14. hereditary galactose intolerance

15. alcohol or drug abuse

16. participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start

17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control

18. patients considered reliable by the investigator

19. acute coronary syndrome =< 6 wks before ICF

20. stroke or Transient Ischemic Attack (TIA) =< 3 months prior to ICF