rescue. Glycemic endpoints measured were A1C and fasting glucose.
In combination with pioglitazone, JANUVIA provided significant improvements in A1C and FPG compared to placebo with pioglitazone (Table 8). Rescue therapy was used in 7% of patients treated with JANUVIA 100 mg and 14% of patients treated with placebo. There was no significant difference between JANUVIA and placebo in body weight change.
Table 8: Glycemic Parameters at Final Visit (24-Week Study) for JANUVIA in Add-on Combination Therapy with Pioglitazone* JANUVIA 100 mg + Pioglitazone Placebo + Pioglitazone
* Intent-to-treat population using last observation on study prior to metformin rescue therapy. † Least squares means adjusted for prior antihyperglycemic therapy status and baseline value. ‡ p<0.001 compared to placebo + pioglitazone.
A1C (%) N = 163 N = 174
Baseline (mean) 8.1 8.0
Change from baseline (adjusted mean†) -0.9 -0.2
Difference from placebo + pioglitazone (adjusted mean†)
(95% CI) -0.7‡
(-0.9, -0.5)
Patients (%) achieving A1C <7% 74 (45%) 40 (23%)
FPG (mg/dL) N = 163 N = 174
Baseline (mean) 168 166
Change from baseline (adjusted mean†) -17 1
Difference from placebo + pioglitazone (adjusted mean†)
(95% CI) -18‡
(-24, -11)
Initial Combination Therapy with Pioglitazone
A total of 520 patients with type 2 diabetes and inadequate glycemic control on diet and exercise participated in a 24-week, randomized, double-blind study designed to assess the efficacy of JANUVIA as initial therapy in combination with pioglitazone. Patients not on antihyperglycemic agents at study entry (<4 weeks cumulative therapy over the past 2 years, and with no treatment over the prior 4 months) with inadequate glycemic control (A1C 8% to 12%) immediately entered the 2-week single-blind placebo run-in period and then were randomized. Approximately equal numbers of patients were randomized to receive initial therapy with 100 mg of JANUVIA in combination with 30 mg of pioglitazone once daily or 30 mg of pioglitazone once daily as monotherapy. There was no glycemic rescue therapy in this study.
Initial therapy with the combination of JANUVIA and pioglitazone provided significant improvements in A1C, FPG, and 2-hour PPG compared to pioglitazone monotherapy (Table 9). The improvement in A1C was generally consistent across subgroups defined by gender, age, race, baseline BMI, baseline A1C, or duration of disease. In this study, patients treated with JANUVIA in combination with pioglitazone had a mean increase in body weight of 1.1 kg compared to pioglitazone alone (3.0 kg vs. 1.9 kg). Lipid effects were generally neutral.
Table 9: Glycemic Parameters at Final Visit (24-Week Study) for JANUVIA in Combination with Pioglitazone as Initial Therapy* JANUVIA 100 mg + Pioglitazone Pioglitazone
* Intent-to-treat population using last observation on study. † Least squares means adjusted for baseline value. ‡ p<0.001 compared to placebo + pioglitazone.
A1C (%) N = 251 N = 246
Baseline (mean) 9.5 9.4
Change from baseline (adjusted mean†) -2.4 -1.5
Difference from pioglitazone (adjusted mean†) (95% CI) -0.9‡
(-1.1, -0.7)&n |
