ONGLYZA (Page 9 of 14)

Add-On Combination Therapy with Glyburide

A total of 768 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 sulfonylurea (SU) in patients with inadequate glycemic control at enrollment (A1C ≥7.5% to ≤10%) on a submaximal dose of SU alone. To qualify for enrollment, patients were required to be on a submaximal dose of SU for 2 months or greater. In this study, ONGLYZA in combination with a fixed, intermediate dose of SU was compared to titration to a higher dose of SU.

Patients who met eligibility criteria were enrolled in a single-blind, 4-week, dietary and exercise lead-in period, and placed on glyburide 7.5 mg once daily. Following the lead-in period, eligible patients with A1C ≥7% to ≤10% were randomized to either 2.5 mg or 5 mg of ONGLYZA add-on to 7.5 mg glyburide or to placebo plus a 10 mg total daily dose of glyburide. Patients who received placebo were eligible to have glyburide up-titrated to a total daily dose of 15 mg. Up-titration of glyburide was not permitted in patients who received ONGLYZA 2.5 mg or 5 mg. Glyburide could be down-titrated in any treatment group once during the 24-week study period due to hypoglycemia as deemed necessary by the investigator. Approximately 92% of patients in the placebo plus glyburide group were up-titrated to a final total daily dose of 15 mg during the first 4 weeks of the study period. Patients who failed to meet specific glycemic goals during the study were treated with metformin rescue, added on to existing study medication. Dose titration of ONGLYZA was not permitted during the study.

In combination with glyburide, ONGLYZA 2.5 mg and 5 mg provided significant improvements in A1C, FPG, and PPG compared with the placebo plus up-titrated glyburide group (Table 7). The proportion of patients who discontinued for lack of glycemic control or who were rescued for meeting prespecified glycemic criteria was 18% in the ONGLYZA 2.5 mg add-on to glyburide group, 17% in the ONGLYZA 5 mg add-on to glyburide group, and 30% in the placebo plus up-titrated glyburide group.

Table 7: Glycemic Parameters at Week 24 in a Placebo-Controlled Study of ONGLYZA as Add-On Combination Therapy with Glyburide *
Efficacy Parameter ONGLYZA 2.5 mg + Glyburide 7.5 mg N=248 ONGLYZA 5 mg + Glyburide 7.5 mg N=253 Placebo + Up-Titrated Glyburide N=267
*
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 + up-titrated glyburide.
§
p-value <0.05 compared to placebo + up-titrated glyburide.

Hemoglobin A1C (%)

N=246

N=250

N=264

Baseline (mean)

8.4

8.5

8.4

Change from baseline (adjusted mean )

−0.5

−0.6

+0.1

Difference from up-titrated glyburide (adjusted mean )

−0.6

−0.7

95% Confidence Interval

(−0.8, −0.5)

(−0.9, −0.6)

Percent of patients achieving A1C <7%

22%§ (55/246)

23%§ (57/250)

9% (24/264)

Fasting Plasma Glucose (mg/dL)

N=247

N=252

N=265

Baseline (mean)

170

175

174

Change from baseline (adjusted mean )

−7

−10

+1

Difference from up-titrated glyburide (adjusted mean )

−8§

−10§

95% Confidence Interval

(−14, −1)

(−17, −4)

2-hour Postprandial Glucose (mg/dL)

N=195

N=202

N=206

Baseline (mean)

309

315

323

Change from baseline (adjusted mean )

−31

−34

+8

Difference from up-titrated glyburide (adjusted mean )

−38§

−42§

95% Confidence Interval

(−50, −27)

(−53, −31)

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