Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial

Pasquel, Francisco J.; Gianchandani, Roma; Rubin, Daniel J.; Dungan, Kathleen; Anzola, Isabel; Gomez, Patricia; Peng, Limin; Hodish, Israel; Bodnar, Timothy W.; Wesorick, David H.; Balakrishnan, Vijay Shankar; Osei, Kwame

doi:10.1016/s2213-8587(16)30402-8

Cited by 142 publications

(137 citation statements)

References 30 publications

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“…In a recent, multicenter, randomized controlled trial, the same group of investigators have shown that sitagliptin along with basal insulin is able to achieve glycemic control that is non-inferior to the basal-bolus insulin therapy. 21 Thus, even in patients with relatively high BG levels at baseline, DPP-4 inhibitor use may obviate the need for nutritional insulin. We restricted our patient population to participants with milder hyperglycemia, who were most likely to respond to DPP-4 inhibitor therapy alone, using clinical criteria often used in the outpatient setting.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients

Garg

Schuman

Hurwitz

et al. 2017

BMJ Open Diab Res Care

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ObjectiveTo evaluate whether saxagliptin is non-inferior to basal-bolus insulin therapy for glycemic control in patients with controlled type 2 diabetes mellitus (T2DM) admitted to hospital with non-critical illnesses.Research design and methodsThis was an open-label, randomized controlled clinical trial. Patients received either saxagliptin or basal-bolus insulin, both with correctional insulin doses. The main study outcome was the mean daily blood glucose (BG) after the first day of randomization.ResultsOf 66 patients completing the study, 33 (age 69±10 years, 40% men) were randomized to saxagliptin and 33 (age 67±10 years, 52% men) to basal-bolus insulin therapy. The mean daily BG was 149.8±22.0 mg/dL in the saxagliptin group and 146.9±30.5 mg/dL in the insulin group (p=0.59). With an observed group difference of 2.9 mg/dL and an a priori margin of 20 mg/dL, inferiority of saxagliptin was rejected in favor of non-inferiority (p=0.007). There was no significant difference in the percentage of high or low BG values. The insulin group received a higher number of insulin injections (2.3±1.7/day vs 1.2±1.9/day; p<0.001) as well as a higher daily insulin dose (13.3±12.9 units/day vs 2.4±3.3 units/day; p<0.001) than did the saxagliptin group. Continuous BG monitoring showed that glycemic variability was lower in the saxagliptin group as compared to the insulin group. Patient satisfaction scores were similar in the two groups.ConclusionsWe conclude that saxagliptin use is non-inferior to basal-bolus insulin in non-critically ill hospitalized patients with T2DM controlled on 0–2 oral agents without insulin. Saxagliptin use may decrease glycemic variability in these patients.Trial registration numberNCT02182895.

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Section: Discussionmentioning

confidence: 99%

Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients

Garg

Schuman

Hurwitz

et al. 2017

BMJ Open Diab Res Care

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“…Based on our previous studies, we have shown that a BG difference less than 1.0 mmol/L was not considered clinically significant . Also based on our previous studies, we assumed the standard deviation of mean daily BG is bounded above by 2.8 mmol/L . With two‐sample t tests or Wilcoxon tests, one sided, alpha = 0.05, 121 participants for each treatment arm would be needed to ensure 80% power to reject the hypothesis that the mean daily BG in patients treated with linagliptin is no more than 1.0 mmol/L higher than that in patients treated with basal‐bolus insulin.…”

Section: Methodsmentioning

confidence: 99%

“…Dipeptidyl dipeptidase‐4 (DPP‐4) inhibitors are oral antidiabetic medications that inhibit the degradation of endogenous glucagon‐like peptide‐1 and can quickly lower blood glucose with a low risk of hypoglycaemia. In two recent multi‐centre, randomized, controlled studies of non‐critically ill medicine and surgery patients, we showed that a DPP‐4 inhibitor, sitagliptin, alone or in combination with insulin glargine, results in similar glycaemic control, with less hypoglycaemia, as compared to glargine and rapid‐acting insulin with meals . However, more than 80% of the patients included in these studies were admitted to general medicine wards.…”

Section: Introductionmentioning

confidence: 99%

Glycaemic efficacy and safety of linagliptin compared to a basal‐bolus insulin regimen in patients with type 2 diabetes undergoing non‐cardiac surgery: A multicentre randomized clinical trial

Vellanki

Rasouli

Baldwin

et al. 2018

Diabetes Obesity Metabolism

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Aims: The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D. Materials and Methods:This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups.Results: Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 AE 2.6 vs 8.8 AE 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 AE 2.3 vs 8.7 AE 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 AE 2.6 vs 9.2 AE 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 AE 3.3 vs 3.1 AE 3.3, P < 0.001) compared to the basal-bolus group.Conclusions: For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.The association between hyperglycaemia and poor clinical outcomes in patients with and without diabetes is well established. 1-5 Extensive data from observational and prospective randomized controlled trials in hospitalized patients have resulted in a strong association between hyperglycaemia and poor clinical outcomes, such as increased mortality, morbidity, length of hospital stay (LOS), infections and overall complications. 1,4,6-8 Most clinical trials in critically ill and in noncritically ill medicine and surgery patients with hyperglycaemia and diabetes have reported that improved glycaemic control reduces LOS, risk of multi-organ failure and systemic infections, 9-12 as well as short-and long-term mortality, 6,11 although the largest trial in critically ill patients showed increased mortality with intensive glucose control. 12 Current clinical guidelines from professional societies recommend basal-bolus insulin regimens as the standard of care for hospitalized patients with type 2 diabetes (T2D). 13,14 Our group has shown that a basal-bolus insulin regimen resulted in improved glycaemic co...

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“…A few recent randomized pilot trials in general medicine and surgery patients reported that a dipeptidyl peptidase 4 inhibitor alone or in combination with basal insulin was well tolerated and resulted in similar glucose control and frequency of hypoglycemia compared with a basal-bolus regimen (39)(40)(41). However, a recent FDA bulletin states that providers should consider discontinuing saxagliptin and alogliptin in people who develop heart failure (42).…”

Section: Noninsulin Therapiesmentioning

confidence: 99%

14. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes—2018

2017

Diabetes Care

156

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The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial

Cited by 142 publications

References 30 publications

Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients

Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients

Glycaemic efficacy and safety of linagliptin compared to a basal‐bolus insulin regimen in patients with type 2 diabetes undergoing non‐cardiac surgery: A multicentre randomized clinical trial

14. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes—2018

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