Table 10. Glycemic Parameters at Week 26 in a Coadministration Study of Alogliptin and Pioglitazone in Patients Inadequately Controlled on Diet and Exercise*
Alogliptin 25 mg Pioglitazone 30 mg Alogliptin 25 mg + Pioglitazone 30 mg
* Intent-to-treat population using last observation carried forward † Least squares means adjusted for treatment, geographic region and baseline value ‡ p˂0.01 compared to alogliptin 25 mg or pioglitazone 30 mg
A1C (%) N=160 N=153 N=158
Baseline (mean) 8.8 8.8 8.8
Change from Baseline (adjusted mean†) -1 -1.2 -1.7
Difference from alogliptin 25 mg (adjusted mean† with 95% confidence interval)   -0.8‡ (-1, -0.5)
Difference from pioglitazone 30 mg (adjusted mean† with 95% confidence interval)   -0.6‡ (-0.8, -0.3)
% of Patients (n/N) achieving A1C ≤ 7% 24%
(40/164) 34%
(55/163) 63%
(103/164)‡
FPG (mg/dL) N=162 N=157 N=162
Baseline (mean) 189 189 185
Change from Baseline (adjusted mean†) -26 -37 -50
Difference from alogliptin 25 mg (adjusted mean† with 95% confidence interval)   -25‡ (-34, -15)
Difference from pioglitazone 30 mg (adjusted mean† with 95% confidence interval)   -13‡ (-22, -4)
Alogliptin and Pioglitazone Coadministration in Patients with Type 2 Diabetes Inadequately Controlled on Metformin Alone

In the second 26-week, double-blind, placebo-controlled study, a total of 1554 patients already on metformin (mean baseline A1C=8.5%) were randomized to one of 12 double-blind 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. Patients were maintained on a stable dose of metformin (median dose=1700 mg) during the treatment period. Coadministration of alogliptin and pioglitazone provided statistically significant improvements in A1C and FPG compared to placebo, to alogliptin alone, or to pioglitazone alone when added to background metformin therapy (Table 11, Figure 3). A total of 4%, 5% or 2% of patients receiving alogliptin 25 mg with 15 mg, 30 mg or 45 mg pioglitazone, 33% of patients receiving placebo, 13% of patients receiving alogliptin 25 mg, and 10%, 15% or 9% of patients receiving pioglitazone 15 mg, 30 mg or 45 mg alone required glycemic rescue.

Improvements in A1C were not affected by gender, age or baseline BMI.

The mean increase in body weight was similar between pioglitazone alone and alogliptin when coadministered with pioglitazone.

Table 11. Glycemic Parameters at Week 26 for Alogliptin and Pioglitazone Alone and in Combination in Patients with Type 2 Diabetes*
Placebo Alogliptin
25 mg Pioglitazone
15 mg Pioglitazone
30 mg Pioglitazone
45 mg Alogliptin
25 mg + Pioglitazone
15 mg Alogliptin
25 mg + Pioglitazone
30 mg Alogliptin
25 mg + Pioglitazone
45 mg
* Intent-to-treat population using last observation carried forward † Least squares means adjusted for treatment, geographic region metformin dose and baseline value ‡