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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:40 - 85
Updated:9/5/2018
Start Date:October 26, 2010
End Date:August 21, 2018

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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.

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.


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 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 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 TIA =< 3 months prior to ICF
We found this trial at
176
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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700 South Torrence
Charlotte, North Carolina 28204
704-374-0030
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2950 Halcyon Ln # 706
Jacksonville, Florida 32223
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
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920 Madison Ave
Memphis, Tennessee 38163
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1800 SW 1 ST #208
Miami, Florida 33135
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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3890 Tampa Rd # 302
Palm Harbor, Florida 34684
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6699 Alvarado Rd.
San Diego, California 92120
619-229-3920
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6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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6804 South Canton
Tulsa, Oklahoma 74136
918-524-5205
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1365 Washington Avenue
Albany, New York 12206
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Anderson, South Carolina 29621
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11220 Elm Lane
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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