Onglyza (Saxagliptin Hydrochloride) - Summary

ONGLYZA SUMMARY

Saxagliptin is an orally-active inhibitor of the DPP4 enzyme.

ONGLYZA (saxagliptin) is indicated for the following:

Monotherapy and Combination Therapy

ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies .]

Important Limitations of Use

ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

ONGLYZA has not been studied in combination with insulin.

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NEWS HIGHLIGHTS

Published Studies Related to Onglyza (Saxagliptin)

Efficacy and safety of saxagliptin in drug-naive Asian patients with type 2 diabetes mellitus: a randomized controlled trial. [2011.11.12]
BACKGROUND: Few studies have assessed the use of new oral anti-diabetic agents in Asian populations. This study assesses the efficacy and safety of saxagliptin versus placebo in Asian patients with type 2 diabetes mellitus (T2DM)... CONCLUSIONS: Saxagliptin improved glycemic control and was well-tolerated in drug-naive Asian patients with T2DM. Copyright (c) 2002 John Wiley & Sons, Ltd. Copyright (c) 2002 John Wiley & Sons, Ltd.

The design and rationale of the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus-Thrombolysis in Myocardial Infarction (SAVOR-TIMI) 53 Study. [2011.11]
CONCLUSION: SAVOR-TIMI 53 is testing the hypothesis that treatment with saxagliptin is safe and reduces CV events in high-risk patients with T2DM. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: A randomized controlled trial. [2011.11]
AIM: To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin alone... CONCLUSION: Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

Effects of saxagliptin on beta-cell stimulation and insulin secretion in patients with type 2 diabetes. [2011.09]
AIM: To study the effect of dipeptidyl peptidase-4 (DPP-4) inhibition with saxagliptin on beta-cell function as reflected by the stimulated insulin secretion rate after an enteral glucose load in patients with type 2 diabetes... CONCLUSIONS: DPP-4 inhibition with saxagliptin improves pancreatic beta-cell function in postprandial and fasting states, and decreases postprandial glucagon concentration. Given the magnitude of enhancement of the insulin response in the fasting state, further study into the effect of DPP-4 inhibition on the beta-cell is warranted. (c) 2011 Blackwell Publishing Ltd.

Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. [2011.07]
BACKGROUND: The mechanism of action of dipeptidyl peptidase-4 inhibitors, such as saxagliptin, makes them suitable for combination therapy in type 2 diabetes mellitus (T2DM). Genetic, cultural, and environmental differences in individuals from different regions of the world may result in differences in treatment response to oral antidiabetic drugs (OADs). This post-hoc subanalysis assessed the efficacy and safety of saxagliptin as add-on therapy to metformin, glyburide, or a thiazolidinedione in patients with inadequately controlled T2DM in the United States... CONCLUSIONS: This post-hoc analysis in a cohort of US patients with T2DM uncontrolled on monotherapy suggests that saxagliptin 2.5 or 5 mg as add-on therapy to OADs results in improvement across key glycemic parameters compared with placebo add-on and was generally safe and well tolerated.

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Clinical Trials Related to Onglyza (Saxagliptin)

Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use [Recruiting]
This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.

Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM [Not yet recruiting]
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)

Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes [Recruiting]
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone [Not yet recruiting]
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration [Not yet recruiting]

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Reports of Suspected Onglyza (Saxagliptin) Side Effects

Pancreatitis (43),  Rash (35),  Blood Glucose Increased (32),  Drug Ineffective (28),  Nausea (25),  Diarrhoea (25),  Dizziness (22),  Pruritus (20),  Abdominal Pain Upper (19),  Oedema Peripheral (18), more >>