Indication

NESINA (alogliptin), KAZANO (alogliptin and metformin HCl), and OSENI (alogliptin and pioglitazone) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. NESINA, KAZANO, and OSENI are not for treatment of type 1 diabetes or diabetic ketoacidosis.

Important Safety Information

Efficacy profile

OSENI clinical study results

In all clinical trials, OSENI was coadministered as alogliptin and pioglitazone.10

In patients on background metformin, OSENI achieved greater A1C reductions than pioglitazone alone at week 26*10



Chart: OSENI 2—CSA, p17


Significantly more patients achieved A1C ≤7.0% with OSENI compared to pioglitazone and alogliptin alone*10

Cahar of OSENI efficacy data

Individual results may vary.

*In a 26-week, double-blind study, 1554 patients already on metformin (median dose 1700 mg) were randomized to one of 12 once-daily treatment groups: placebo; 12.5 mg or 25 mg of alogliptin alone; 15 mg, 30 mg, or 45 mg of pioglitazone alone; or 12.5 mg or 25 mg of alogliptin in combination with 15 mg, 30 mg, or 45 mg of pioglitazone. The primary endpoint was A1C reduction from baseline with the coadministration of alogliptin and pioglitazone compared to pioglitazone alone at week 26. Results for reductions in A1C reflect an adjusted least squares mean value.4,10

P≤0.001 vs pioglitazone and alogliptin alone.

P≤0.01 vs pioglitazone and alogliptin alone.


In a study of patients inadequately controlled on diet and exercise, OSENI 25/30 mg provided powerful A1C reductions§10

Patients achieved a –1.0% change (mean baseline 8.8%; n=160) from baseline with alogliptin 25 mg, a –1.2% change (mean baseline 8.8%; n=153) with pioglitazone 30 mg, and a –1.7% change (mean baseline 8.8%; n=158; P<0.01 vs individual comparators) from baseline with OSENI 25/30 mg.§10



In the same study, significantly more patients achieved A1C ≤7.0% with OSENI compared to pioglitazone and alogliptin alone§10

  • In a study of patients inadequately controlled on diet and exercise, 63%|| (n/N=103/164) of patients achieved A1C ≤7.0% with OSENI 25/30 mg vs 24% (n/N=40/164) with alogliptin 25 mg and 34% (n/N=55/163) with pioglitazone 30 mg.§10

Individual results may vary.

§In a 26-week, double-blind, active-controlled study, 655 patients with type 2 diabetes inadequately controlled on diet and exercise alone were randomized to receive alogliptin 25 mg alone, pioglitazone 30 mg alone, coadministration of alogliptin 12.5 mg and pioglitazone 30 mg, or alogliptin 25 mg and pioglitazone 30 mg once daily. Primary endpoint was the change in A1C from baseline with the coadministration of alogliptin 25 mg with pioglitazone 30 mg vs individual component regimens alone at week 26. Results for A1C reductions reflect an adjusted least squares mean value.5,10

||P≤0.01 vs pioglitazone and alogliptin alone.


Safety and tolerability profile for OSENI

Review safety profile for OSENI

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