ONGLYZA (Page 8 of 14)

Add-On Combination Therapy with a Thiazolidinedione

A total of 565 patients with type 2 diabetes participated in this 24-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ONGLYZA in combination with a thiazolidinedione (TZD) in patients with inadequate glycemic control (A1C ≥7% to ≤10.5%) on TZD alone. To qualify for enrollment, patients were required to be on a stable dose of pioglitazone (30-45 mg once daily) or rosiglitazone (4 mg once daily or 8 mg either once daily or in two divided doses of 4 mg) for at least 12 weeks.

Patients who met eligibility criteria were enrolled in a single-blind, 2-week, dietary and exercise placebo lead-in period during which patients received TZD at their pre-study dose. Following the lead-in period, eligible patients were randomized to 2.5 mg or 5 mg of ONGLYZA or placebo in addition to their current dose of TZD. Patients who failed to meet specific glycemic goals during the study were treated with metformin rescue, added on to existing study medications. Dose titration of ONGLYZA or TZD was not permitted during the study. A change in TZD regimen from rosiglitazone to pioglitazone at specified, equivalent therapeutic doses was permitted at the investigator’s discretion if believed to be medically appropriate.

ONGLYZA 2.5 mg and 5 mg add-on to TZD provided significant improvements in A1C, FPG, and PPG compared with placebo add-on to TZD (Table 6). The proportion of patients who discontinued for lack of glycemic control or who were rescued for meeting prespecified glycemic criteria was 10% in the ONGLYZA 2.5 mg add-on to TZD group, 6% for the ONGLYZA 5 mg add-on to TZD group, and 10% in the placebo add-on to TZD group.

Table 6: Glycemic Parameters at Week 24 in a Placebo-Controlled Study of ONGLYZA as Add-On Combination Therapy with a Thiazolidinedione *
Efficacy Parameter ONGLYZA 2.5 mg + TZD N=195 ONGLYZA 5 mg + TZD N=186 Placebo + TZD N=184
Intent-to-treat population using last observation on study or last observation prior to metformin rescue therapy for patients needing rescue
Least squares mean adjusted for baseline value
p-value <0.0001 compared to placebo + TZD
p-value <0.05 compared to placebo + TZD

Hemoglobin A1C (%)




Baseline (mean)




Change from baseline (adjusted mean )




Difference from placebo (adjusted mean )



95% Confidence Interval

(−0.6, −0.2)

(−0.8, −0.4)

Percent of patients achieving A1C <7%

42% (81/192)

42% (77/184)

26% (46/180)

Fasting Plasma Glucose (mg/dL)




Baseline (mean)




Change from baseline (adjusted mean )




Difference from placebo (adjusted mean )



95% Confidence Interval

(−20, −3)

(−23, −6)

2-hour Postprandial Glucose (mg/dL)




Baseline (mean)




Change from baseline (adjusted mean )




Difference from placebo (adjusted mean )



95% Confidence Interval

(−56, −24)

(−66, −34)

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