Saxagliptin as initial therapy in treatment-naive Indian adults with type 2 diabetes mellitus inadequately controlled with diet and exercise alone: a randomized, double-blind, placebo-controlled, phase IIIb clinical study

Kumar, K M Prasanna; Jain, Sunil; Tou, Conrad; Schützer, Kajs-Marie

doi:10.1007/s13410-014-0191-1

Cited by 13 publications

(15 citation statements)

References 15 publications

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“…Of the 22 089 hits retrieved from our search, 144 studies met our inclusion criteria (Figure ). An agreement value ( κ ) of 80% was achieved for studies requiring detailed analysis and extraction.…”

Section: Resultsmentioning

confidence: 99%

Risk of any hypoglycaemia with newer antihyperglycaemic agents in patients with type 2 diabetes: A systematic review and meta‐analysis

Kamalinia

Josse

Donio

et al. 2019

Endocrino Diabet & Metabol

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Objectives: For patients with type 2 diabetes, newer antihyperglycaemic agents (AHA), including the dipeptidyl peptidase IV inhibitors (DPP4i), glucagon-like peptide-1 receptor agonists (GLP1RA) and sodium glucose co-transporter 2 inhibitors (SGLT2i) offer a lower risk of hypoglycaemia relative to sulfonylurea or insulin.However, it is not clear how AHA compare to placebo on risk of any hypoglycaemia.This study evaluates the risk of any and severe hypoglycaemia with AHA and metformin relative to placebo. Design: A systematic review and meta-analysis was conducted of randomized, placebo-controlled trials ≥12 weeks in duration. MEDLINE, Embase and the Cochrane Library were searched up to April 16, 2019. Studies allowing use of other diabetes medications were excluded. Mantel-Haenszel risk ratio with 95% confidence intervals were used to pool estimates based on class of AHA and number of concomitant therapies used.Patients: Eligible studies enrolled patients with type 2 diabetes ≥18 years of age.Results: 144 studies met our inclusion criteria. Any hypoglycaemia was not increased with AHA when used as monotherapy (DPP4i (RR 1.12; 95% CI 0.81-1.56), GLP1RA (1.77; 0.91-3.46), SGLT2i (1.34; 0.83-2.15)), or as add-on to metformin (DPP4i (0.95; 0.67-1.35), GLP1RA (1.24; 0.80-1.91), SGLT2i (1.29; 0.91-1.83)) or as triple therapy (1.13; 0.67-1.91). However, metformin monotherapy (1.73; 1.02-2.94) and dual therapy initiation (3.56; 1.79-7.10) was associated with an increased risk of any hypoglycaemia. Severe hypoglycaemia was rare not increased for any comparisons. Conclusions:Metformin and the simultaneous initiation of dual therapy, but not AHA used alone or as single add-on combination therapy, was associated with an increased risk of any hypoglycaemia relative to placebo. K E Y W O R D S diabetes mellitus, type 2, dipeptidyl peptidase IV inhibitor, glucagon-like peptide-1 receptor agonist, hypoglycaemia, sodium glucose co-transporter 2 inhibitor S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section. How to cite this article: Kamalinia S, Josse RG, Donio PJ, Leduc L, Shah BR, Tobe SW. Risk of any hypoglycaemia with newer antihyperglycaemic agents in patients with type 2 diabetes: A systematic review and meta-analysis. Endocrinol Diab Metab. 2020;3:e00100. https ://doi.

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Section: Resultsmentioning

confidence: 99%

Risk of any hypoglycaemia with newer antihyperglycaemic agents in patients with type 2 diabetes: A systematic review and meta‐analysis

Kamalinia

Josse

Donio

et al. 2019

Endocrino Diabet & Metabol

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“…Both groups received a range of background medications, including metformin, sulfonylureas, and thiazolidinediones; the control group received both active medications and placebo. In several studies, a titration of background treatment [8,[33][34][35]45] or a titration of double-blind study drug [5,30,31,46,47] was permitted; in the majority of studies, rescue was permitted [5][6][7][8][9]32,33,[46][47][48][49][50][51]. These factors complicate interpretation of the findings.…”

Section: Discussionmentioning

confidence: 99%

Safety of saxagliptin: events of special interest in 9156 patients with type 2 diabetes mellitus

Hirshberg

Parker

Edelberg

et al. 2014

Diabetes Metabolism Res

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“…In 4 individual phase 3 trials, saxagliptin monotherapy (2.5 or 5 mg QD) significantly reduced HbA1c from baseline at 24 weeks compared with placebo [10,[22][23][24]. Consistent with the characteristics of a DPP-4 inhibitor [5,11], saxagliptin was associated with a low risk of hypoglycemia and with weight neutrality [10,[22][23][24]. A pooled analysis of these 4 phase 3 saxagliptin monotherapy trials was performed to better characterize the therapeutic profile of saxagliptin monotherapy for the treatment of T2DM.…”

Section: Resultsmentioning

confidence: 99%

“…Aside from insulin, most medications are expected to reduce HbA1c levels by 0.5% to 2.0% when administered as monotherapy [8]. A reduction in HbA1c of 0.5% is generally considered to be a clinically meaningful and therapeutic response [9,10]. Metformin, a biguanide, is the preferred initial pharmacologic therapy for T2DM because it has a long-standing evidence base of clinical efficacy and no associated risk for weight gain or hypoglycemia [2,11].…”

Section: Recent Guidelines From the American Diabetes Association Andmentioning

confidence: 99%

A Pooled Analysis of the Efficacy and Safety of Saxagliptin as Monotherapy in Patients with Type 2 Diabetes

Bryzinski¹

2015

J Diabetes Metab

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Objective: Saxagliptin is a once-daily, orally administered dipeptidyl peptidase-4 inhibitor, approved for the treatment of type 2 diabetes mellitus (T2DM). In 4 double-blind, placebo-controlled, phase 3 trials, saxagliptin 2.5 or 5 mg significantly reduced glycated hemoglobin (HbA1c) from baseline at 24 weeks. A pooled analysis of these clinical trials was conducted to assess the therapeutic profile of saxagliptin monotherapy. Methods: A post hoc pooled analysis of 4 saxagliptin monotherapy trials in patients with T2DM was conducted to determine the consistency of treatment effects, assessed as change from baseline in HbA1c at week 24, in patient subgroups stratified by race, sex, age, and baseline HbA1c. Secondary end points included change from baseline at week 24 in fasting plasma glucose and proportion of patients achieving HbA1c <7%. Safety assessments included adverse event reports, laboratory test results, and vital sign measurements. Results: At week 24, saxagliptin 2.5 mg, saxagliptin 5 mg, and placebo decreased HbA1c from baseline by −0.66%, −0.64%, and −0.13% respectively (P<0.0001 for each saxagliptin dose vs placebo). The treatment effects of saxagliptin 2.5 5 mg on HbA1c were consistent across subgroups, and no treatment interactions were observed, with the exception of baseline HbA1c (P=0.003). The overall occurrence of adverse events was similar among groups (66.0% saxagliptin 2.5 mg; 53.0% saxagliptin 5 mg; 45.3% placebo). The incidence of hypoglycemic events was low and comparable among groups, and no cases of confirmed hypoglycemia were reported. Conclusions: Consistent with findings from individual studies, this pooled analysis showed saxagliptin to significantly improve glycemic measures compared with placebo. Outcomes confirmed saxagliptin treatment was associated with a weight-neutral effect and a low risk for hypoglycemia. Based on the overall findings, saxagliptin has a favorable benefit:risk profile and may be considered an alternative first-line therapy for patients with T2DM in whom metformin is contraindicated or not tolerated.

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Saxagliptin as initial therapy in treatment-naive Indian adults with type 2 diabetes mellitus inadequately controlled with diet and exercise alone: a randomized, double-blind, placebo-controlled, phase IIIb clinical study

Cited by 13 publications

References 15 publications

Risk of any hypoglycaemia with newer antihyperglycaemic agents in patients with type 2 diabetes: A systematic review and meta‐analysis

Risk of any hypoglycaemia with newer antihyperglycaemic agents in patients with type 2 diabetes: A systematic review and meta‐analysis

Safety of saxagliptin: events of special interest in 9156 patients with type 2 diabetes mellitus

A Pooled Analysis of the Efficacy and Safety of Saxagliptin as Monotherapy in Patients with Type 2 Diabetes

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