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Oseni (Alogliptin Benzoate / Pioglitazone Hydrochloride) - Summary

 
 



WARNING: CONGESTIVE HEART FAILURE

  • Thiazolidinediones, including pioglitazone, which is a component of OSENI, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions].
  • After initiation of OSENI and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in OSENI must be considered.
  • OSENI is not recommended in patients with symptomatic heart failure.
  • Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions].
 

OSENI SUMMARY

OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: alogliptin and pioglitazone.

Monotherapy and Combination Therapy

OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings when treatment with both alogliptin and pioglitazone is appropriate [see Clinical Studies].

Limitation of Use

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

Use with caution in patients with liver disease [see Warnings and Precautions ].


See all Oseni indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Oseni (Alogliptin / Pioglitazone)

The Practical Evidence of Antidiabetic Combination Therapy in Korea [Recruiting]
This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 diabetic patients in Korea.

Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan [Completed]
The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus [Completed]
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus

Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan [Completed]
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.

Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes. [Completed]
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

more trials >>


Page last updated: 2013-07-31

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