Sitagliptin, a DPP-4 inhibitor for the treatment of patients with type 2 diabetes: a review of recent clinical trials

Karasik, Avraham; Aschner, Pablo; Katzeff, Harvey L.; Davies, Michael J.; Stein, Peter

doi:10.1185/030079908x261069

Cited by 140 publications

(95 citation statements)

References 56 publications

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“…The HbA1c treatment response was generally consistent across patient subgroups, except in the Hispanic or Latino ethnicity subgroup. These data for the Hispanic or Latino subgroup are not consistent with results from previous studies with sitagliptin [15]. Patients randomised in this trial were on long-acting, intermediate-acting or premixed insulin therapy alone or in combination with metformin.…”

Section: Discussioncontrasting

confidence: 92%

“…The total number of hypoglycaemic episodes was 155 in the sitagliptin group and 76 in the placebo group. The mean number of hypoglycaemic episodes for patients reporting at least one episode was 3.1 (range [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] in the sitagliptin group and 3.0 (range 1-19) in the placebo group. In the sitagliptin and placebo groups, the incidence of hypoglycaemia was slightly higher in the first 8 weeks of the double-blind treatment period compared with the subsequent 16 weeks.…”

Section: Safetymentioning

confidence: 99%

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Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes

Vilsbøll

Rosenstock

Yki‐Järvinen

et al. 2009

Diabetes Obesity Metabolism

286

267

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Objective: To evaluate the efficacy and tolerability of sitagliptin when added to insulin therapy alone or in combination with metformin in patients with type 2 diabetes. Methods:After a 2 week placebo run-in period, eligible patients inadequately controlled on long-acting, intermediate-acting or premixed insulin (HbA1c ≥7.5% and ≤11%), were randomised 1:1 to the addition of once-daily sitagliptin 100 mg or matching placebo over a 24-week study period. The study capped the proportion of randomised patients on insulin plus metformin at 75%. Further, the study capped the proportion of randomised patients on premixed insulin at 25%. The metformin dose and the insulin dose were to remain stable throughout the study. The primary endpoint was HbA1c change from baseline at week 24.Results: Mean baseline characteristics were similar between the sitagliptin (n = 322) and placebo (n = 319) groups, including HbA1c (8.7 vs.8.6%), diabetes duration (13 vs. 12 years), body mass index (31.4 vs. 31.4 kg/m 2 ), and total daily insulin dose (51 vs. 52 IU), respectively. At 24 weeks, the addition of sitagliptin significantly (p < 0.001) reduced HbA1c by 0.6% compared with placebo (0.0%). A greater proportion of patients achieved an HbA1c level <7% while randomised to sitagliptin as compared with placebo (13 vs. 5% respectively; p < 0.001). Similar HbA1c reductions were observed in the patient strata defined by insulin type (long-acting and intermediate-acting insulins or premixed insulins) and by baseline metformin treatment. The addition of sitagliptin significantly (p < 0.001) reduced fasting plasma glucose by 15.0 mg/dl (0.8 mmol/l) and 2-h postmeal glucose by 36.1 mg/dl (2.0 mmol/l) relative to placebo. A higher incidence of adverse experiences was reported with sitagliptin (52%) compared with placebo (43%), due mainly to the increased incidence of hypoglycaemia (sitagliptin, 16% vs. placebo, 8%). The number of hypoglycaemic events meeting the protocol-specified criteria for severity was low with sitagliptin (n = 2) and placebo (n = 1). No significant change from baseline in body weight was observed in either group. Conclusion:In this 24-week study, the addition of sitagliptin to ongoing, stable-dose insulin therapy with or without concomitant metformin improved glycaemic control and was generally well tolerated in patients with type 2 diabetes.

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Section: Discussioncontrasting

confidence: 92%

Section: Safetymentioning

confidence: 99%

Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes

Vilsbøll

Rosenstock

Yki‐Järvinen

et al. 2009

Diabetes Obesity Metabolism

286

267

View full text Add to dashboard Cite

show abstract

“…9 Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor has been shown to improve glycemic control and to be welltolerated in large multinational, placebo-controlled and active-controlled trials both as monotherapy and when given in combination with other oral anti diabetic agents. 10 DPP-4 inhibition leads to an increase in the concentration of the incretins i.e. glucagon like peptide-1 and glucose dependent insulinotropic polypeptide.…”

Section: Introductionmentioning

confidence: 99%

Comparative efficacy and safety of DPP-4 inhibitors and α-glucosidase inhibitors as add on therapy in type 2 diabetes

Sahai

Sharma

Dhasmana

et al. 2018

Int J Basic Clin Pharmacol

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Background: Diabetes mellitus (DM) is a spectrum of metabolic disorders as a consequence of different pathogenic mechanisms resulting in hyperglycemia. A genetic predisposition to develop β-cell dysfunction synergizes with insulin resistance to lead to type 2 DM. Adequate management of type 2 DM requires institution of non pharmacological treatment followed by pharmacological treatment. Monotherapy is started initially followed by combination therapy (dual/triple). Sitagliptin, a DPP-4 inhibitor and voglibose, an α-glucosidase inhibitor has been implicated as an add on therapy to metformin and glimepiride. So, we aimed to assess the efficacy and safety of the sitagliptin and voglibose as add on therapy to metformin and glimepitide in type 2 DM.Methods: This open label randomized control trial was conducted in the department of Pharmacology among patients attending medicine OPD of a tertiary care hospital. 80 patients were randomly divided into two groups of 40 patients each. group A:sitagliptin + metformin + glimepiride and group B:voglibose + metformin + glimepiride. Patients were followed every week for a period of 12 weeks. Data was analysed using paired t test, unpaired t test and chi square test.Results: There was a significant decrease in HbA1c, FPG and PPG in both the groups. Intergroup comparison at 4, 8 and 12 weeks showed a better improvement in glycemic control in group A as compared to group B.Conclusions: Sitagliptin showed a better glycemic control than that with voglibose in patients with uncontrolled type 2 DM on metformin and glimepiride.

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“…Some detailed reviews of published studies have been recently published [1,2,5]; furthermore, some metaanalyses have been performed [1,6e8]. However, currently available meta-analyses included only published studies, without any attempt at retrieving data from completed and publicly disclosed, although not formally published, clinical trials.…”

Section: Introductionmentioning

confidence: 99%

“…Oral Dipeptidyl Peptidase-4 (DPP-4) inhibitors sitagliptin [1] and vildagliptin [2], which increase circulating levels of Glucagon-Like Peptide-1 (GLP-1), have recently been approved for use in type 2 diabetes; other molecules of the same class (such as saxagliptin and alogliptin) are under development.…”

Section: Introductionmentioning

confidence: 99%

Dipeptydil peptidase-4 inhibitors in type 2 diabetes: A meta-analysis of randomized clinical trials

Monami

Iacomelli

Marchionni

et al. 2010

Nutrition, Metabolism and Cardiovascular Diseases

164

108

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Background and Aim: The role of Dipeptidyl Peptidase-4 (DPP-4) inhibitors in the treatment of type 2 diabetes is debated; many recent trials, which were not included in previous meta-analyses, could add relevant information. Methods and Results: All available randomized controlled trials (RCTs), either published or unpublished, performed in type 2 diabetic patients with DPP-4 inhibitors, with a duration >12 weeks were meta-analyzed for HbA1c, BMI, hypoglycemia, and other adverse events. A total of 41 RCTs (9 of which are unpublished) was retrieved and included in the analysis. Gliptins determine a significant improvement of HbA1c in comparison with a placebo (À0.7 [À0.8:À0.6]), with a low risk of hypoglycemia. DPP-4 inhibitors show a similar efficacy in monotherapy and in combination with other agents. The risk of cardiovascular events and all-cause death with DPP-4 inhibitors is 0. 76 [0.46e1.28] and 0.78 [0.40e1.51], respectively. Conclusions: DPP-4 inhibitors reduce HbA1c, although to a lesser extent than sulphonylureas, with no weight gain and no hypoglycemic risk; further data are needed to assess their longterm safety. ª

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Sitagliptin, a DPP-4 inhibitor for the treatment of patients with type 2 diabetes: a review of recent clinical trials

Cited by 140 publications

References 56 publications

Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes

Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes

Comparative efficacy and safety of DPP-4 inhibitors and α-glucosidase inhibitors as add on therapy in type 2 diabetes

Dipeptydil peptidase-4 inhibitors in type 2 diabetes: A meta-analysis of randomized clinical trials

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