Efficacy and safety of linagliptin in Hispanic/Latino patients with type 2 diabetes mellitus: a pooled analysis from six randomized placebo-controlled phase 3 trials

Davidson, Jaime A.; Lajara, Rosemarie; Aguilar, Richard; Mattheus, Michaela; Woerle, Hans-Juergen; Eynatten, Maximilian von

doi:10.1136/bmjdrc-2014-000020

Cited by 7 publications

(3 citation statements)

References 36 publications

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“…The glycemic efficacy and safety profile of sitagliptin in Hispanic patients observed in the analysis reported here are consistent with those previously reported for the entire populations of patients who participated in the studies which provided the data for this analysis and with those observed in the non-Hispanic cohort in the same trials. The results are also consistent with a similar analysis of Hispanic patients using data pooled from studies of linagliptin, another dipeptidyl-peptidase-4 inhibitor [ 24 ].…”

Section: Discussionsupporting

confidence: 87%

Efficacy and Safety of Sitagliptin in Hispanic/Latino Patients with Type 2 Diabetes: A Pooled Analysis from Ten Randomized, Placebo-Controlled Phase 3 Clinical Trials

et al. 2018

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IntroductionTo assess the efficacy and safety profile of the dipeptidyl-peptidase-4 inhibitor sitagliptin in a population of self-identified Hispanic/Latino patients with type 2 diabetes.MethodsData were pooled from ten randomized, double-blind studies in which subjects were treated with sitagliptin 100 mg/day (as mono- or combination therapy) or placebo, and used to evaluate the glycemic efficacy, safety, and tolerability of sitagliptin compared with placebo after 24 weeks of treatment.ResultsA total of 804 Hispanic/Latino patients were included in the analysis. Baseline characteristics in the treatment groups were similar (mean baseline HbA1c of approximately 8.5%). The LS mean HbA1c changes from baseline were − 0.94% with sitagliptin and − 0.32% with placebo, and the between-group difference was − 0.62%, p < 0.001. After 24 weeks of treatment, 35% and 18% of subjects were at the HbA1c goal of < 7% in the sitagliptin and placebo groups, respectively. Body weight increased slightly in both treatment groups. Incidences of adverse events of hypoglycemia were similar and low (1.9% and 1.4% for sitagliptin and placebo, respectively) in both groups in studies in which insulin or sulfonylurea were not used and were similar (9% and 11% for sitagliptin and placebo, respectively) when all studies were included. Overall safety and tolerability of treatment with sitagliptin and placebo were similar. No clinically meaningful differences between the safety profile of sitagliptin in the Hispanic/Latino population analyzed here and broader populations previously evaluated were observed.ConclusionIn this pooled analysis of sitagliptin therapy vs placebo in Hispanic/Latino patients, sitagliptin provided significant improvement in glycemic control and was generally well tolerated.FundingMerck & Co., Inc., Kenilworth, NJ, USA.

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Section: Discussionsupporting

confidence: 87%

Efficacy and Safety of Sitagliptin in Hispanic/Latino Patients with Type 2 Diabetes: A Pooled Analysis from Ten Randomized, Placebo-Controlled Phase 3 Clinical Trials

et al. 2018

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“…Low rates of AEs and incidence of hypoglycemia were observed in similar proportions in linagliptin and placebo-treated patients 56 . Long-term treatment of Japanese subjects with T2DM with linagliptin as monotherapy improved HbA 1c levels with no effect on body weight and few serious AEs 57 .…”

Section: Linagliptinmentioning

confidence: 71%

Racial/ethnic disparities in prevalence and care of patients with type 2 diabetes mellitus

Ferdinand

Nasser

2015

Current Medical Research and Opinion

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Background: As of 2012, nearly 10% of Americans had diabetes mellitus. People with diabetes are at approximately double the risk of premature death compared with those in the same age groups without the condition. While the prevalence of diabetes has risen across all racial/ethnic groups over the past 30 years, rates are higher in minority populations. The objective of this review article is to evaluate the prevalence of diabetes and disease-related comorbidities as well as the primary endpoints of clinical studies assessing glucoselowering treatments in African Americans, Hispanics, and Asians.

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“…Furthermore, the efficacy of linagliptin was maintained irrespective of patients' renal function [27][28][29] , age 30 , race or ethnicity [31][32][33][34] , or duration of T2DM 35 .…”

Section: Linagliptinmentioning

confidence: 99%

Single-pill combination therapy for type 2 diabetes mellitus: linagliptin plus empagliflozin

Aronson

2015

Current Medical Research and Opinion

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Efficacy and safety of linagliptin in Hispanic/Latino patients with type 2 diabetes mellitus: a pooled analysis from six randomized placebo-controlled phase 3 trials

Cited by 7 publications

References 36 publications

Efficacy and Safety of Sitagliptin in Hispanic/Latino Patients with Type 2 Diabetes: A Pooled Analysis from Ten Randomized, Placebo-Controlled Phase 3 Clinical Trials

Efficacy and Safety of Sitagliptin in Hispanic/Latino Patients with Type 2 Diabetes: A Pooled Analysis from Ten Randomized, Placebo-Controlled Phase 3 Clinical Trials

Racial/ethnic disparities in prevalence and care of patients with type 2 diabetes mellitus

Single-pill combination therapy for type 2 diabetes mellitus: linagliptin plus empagliflozin

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