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)
Warnings and Precautions].
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
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
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.
Page last updated: 2013-07-31