Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial
Open accessAbstract
IMPORTANCE: Type 2 diabetes is associated with increased cardiovascular risk. In placebo-controlled cardiovascular safety trials, the dipeptidyl peptidase-4 inhibitor linagliptin demonstrated noninferiority, but it has not been tested against an active comparator. OBJECTIVE: This trial assessed cardiovascular outcomes of linagliptin vs glimepiride (sulfonylurea) in patients with relatively early type 2 diabetes and risk factors for or established atherosclerotic cardiovascular disease. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, active-controlled, noninferiority trial, with participant screening from November 2010 to December 2012, conducted at 607 hospital and primary care sites in 43 countries involving 6042 participants. Adults with type 2 diabetes, glycated hemoglobin of 6.5% to 8.5%, and elevated cardiovascular risk were eligible for inclusion. Elevated cardiovascular risk was defined as documented atherosclerotic cardiovascular disease, multiple cardiovascular risk factors, aged at least 70 years, and evidence of microvascular complications. Follow-up ended in August 2018. INTERVENTIONS: Patients were randomized to receive 5 mg of linagliptin once daily (n = 3023) or 1 to 4 mg of glimepiride once daily (n = 3010) in addition to usual care. Investigators were encouraged to intensify glycemic treatment, primarily by adding or adjusting metformin, α-glucosidase inhibitors, thiazolidinediones, or insulin, according to clinical need. MAIN OUTCOMES AND MEASURES: The primary outcome was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke with the aim to establish noninferiority of linagliptin vs glimepiride, defined by the upper limit of the 2-sided 95.47% CI for the hazard ratio (HR) of linagliptin relative to glimepiride of less than 1.3. RESULTS: Of 6042 participants randomized, 6033 (mean age, 64.0 years; 2414 [39.9%] women; mean glycated hemoglobin, 7.2%; median duration of diabetes, 6.3 years; 42% with macrovascular disease; 59% had undergone metformin monotherapy) were treated and analyzed. The median duration of follow-up was 6.3 years. The primary outcome occurred in 356 of 3023 participants (11.8%) in the linagliptin group and 362 of 3010 (12.0%) in the glimepiride group (HR, 0.98 [95.47% CI, 0.84-1.14]; P < .001 for noninferiority), meeting the noninferiority criterion but not superiority (P = .76). Adverse events occurred in 2822 participants (93.4%) in the linagliptin group and 2856 (94.9%) in the glimepiride group, with 15 participants (0.5%) in the linagliptin group vs 16 (0.5%) in the glimepiride group with adjudicated-confirmed acute pancreatitis. At least 1 episode of hypoglycemic adverse events occurred in 320 (10.6%) participants in the linagliptin group and 1132 (37.7%) in the glimepiride group (HR, 0.23 [95% CI, 0.21-0.26]). CONCLUSIONS AND RELEVANCE: Among adults with relatively early type 2 diabetes and elevated cardiovascular risk, the use of linagliptin compared with glimepiride over a median 6.3 years resulted in a noninferior risk of a composite cardiovascular outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01243424.
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In people at high cardiovascular risk, no difference in the incidence of major adverse cardiovascular events was found between glimepiride and linagliptin.
“and no difference in the incidence of MACE was found in people at high cardiovascular risk treated with glimepiride or linagliptin (194), a medication whose cardiovascular safety was demonstrated in a population at high cardiovascular and renal risk (195).”
Studies have been limited by small sample sizes in combination therapy subgroups and trials have not consistently shown benefit for the combination of SGLT2is and GLP-1RAs on cardiovascular and kidney outcomes.
“Studies have been limited by small sample sizes in combination therapy subgroups and trials have not consistently shown benefit for the combination of SGLT2is and GLP-1RAs on cardiovascular and kidney outcomes.73,112”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [73]
The Trial Participants and Limitations sections describe a linagliptin-versus-glimepiride trial, not studies of combined SGLT2 inhibitors and GLP-1 receptor agonists. Searches for that combination, small subgroups, and cardiovascular or kidney outcomes found no passage addressing the claim. Page numbers were unavailable in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredBased on the findings of statistical non-inferiority of linagliptin vs. placebo in CARMELINA coupled with the non-inferiority of linagliptin vs. glimepiride demonstrated in CAROLINA, one might conclude that glimepiride is most likely not different from placebo with regards to cardiovascular safety.
“Based on the findings of statistical non-inferiority of linagliptin vs. placebo in CARMELINA coupled with the non-inferiority of linagliptin vs. glimepiride demonstrated in CAROLINA, one might conclude that glimepiride is most likely not different from placebo with regards to CV safety.180”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [180]
In the CAROLINA trial, linagliptin was compared with the active comparator glimepiride, demonstrating no difference in any assessed cardiovascular or kidney outcome, though noting a higher risk of hypoglycaemia with glimepiride.
“In the CAROLINA (Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes) trial, linagliptin was compared with the active comparator glimepiride, demonstrating no difference in any assessed CV or kidney outcome, though noting a higher risk of hypoglycaemia with glimepiride.180”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [180]
In the CAROLINA randomized trial, while glimepiride was associated with significantly more hypoglycaemia than the DPP-4 inhibitor linagliptin, MACE did not differ between the two randomized groups.
“Likewise, in the CAROLINA randomized trial, while glimepiride was associated with significantly more hypoglycaemia than the DPP-4 inhibitor linagliptin, MACE did not differ between the two randomized groups.180”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [180]
Linagliptin safely lowers HbA1c in patients with T2DM and CKD.
“Linagliptin safely lowers HbA1c in patients with T2DM and CKD”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [180]
Linagliptin does not reduce risk of CVD or kidney failure in patients with T2DM and CKD.
“but does not reduce risk of CVD or kidney failure.180”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [180]
In CAROLINA, there was no difference in the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients treated with glimepiride versus linagliptin, albeit with a marked increased risk of hypoglycemia with the sulfonylurea.
“there was no difference in the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients treated with glimepiride versus linagliptin, albeit with a marked increased risk of hypoglycemia with the sulfonylurea”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [204]
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- Authors
- Rosenstock, J., Kahn, S. E., Johansen, O. E., Zinman, B., Espeland, M. A., Woerle, H. J., Pfarr, E., Keller, A., Mattheus, M., Baanstra, D., Meinicke, T., George, J. T., von Eynatten, M., McGuire, D. K., Marx, N., & for the CAROLINA Investigators
- Affiliations
- Dallas Diabetes Research Center (US)
- University of Washington (US)
- Boehringer Ingelheim (Norway) (NO)
- Mount Sinai Hospital (CA)
- Wake Forest University Health Sciences (US)
- Universität Ulm (DE)
- Boehringer Ingelheim (Germany) (DE)
- Boehringer Ingelheim (Netherlands) (NL)
- Boehringer Ingelheim International GmbH & Co KG, Ingelheim, Germany
- The University of Texas Southwestern Medical Center (US)
- Universitätsklinikum Aachen (DE)
- Corresponding author
- Marx, Nikolaus
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2019-09-24
- Volume
- 322
- Issue
- 12
- Pages
- 1155
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC6763993
- OpenAlex
- W2974098728
- Cited by
- 612
- References
- 22
- Citations by year
- 2026: 34 · 2025: 62 · 2024: 57 · 2023: 78 · 2022: 104 · 2021: 105 · 2020: 148 · 2019: 21 · 2018: 2 · 2017: 1
- FWCI
- 76.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Deutsche Forschungsgemeinschaft (SFBTRR219, TRR219)
- Eisai
- Novo Nordisk
- Esperion Therapeutics
- Janssen Research and Development
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- linagliptin, glimepiride, type 2 diabetes, major adverse cardiovascular events, cardiovascular safety, non-inferiority, DPP-4 inhibitors, sulfonylureas, cardiovascular mortality, myocardial infarction, stroke, atherosclerotic cardiovascular disease, glycemic control, metformin, antihypertensive therapy, antidiabetic therapy
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