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Clinical Efficacy

DURATION-3: 3-year Clinical Trial Results

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Only once-weekly BYDUREON is proven to provide 3 years of significant and sustained A1C reductions and weight loss.1,2 Learn more about how BYDUREON impacted A1C and weight in the DURATION-3 clinical trial below.

BYDUREON is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.


Study Design

DURATION-3: 3-year, randomized, open-label study with a core 26-week phase with a primary endpoint of change in A1C from baseline at 26 weeks, and a prespecified 130-week extension phase in which patients continued randomized treatment. The primary endpoint at 156 weeks was change in A1C from baseline. In this study, adult type 2 diabetes patients with suboptimal glycemic control (A1C 7.1%-11%) despite maximum tolerated doses of metformin alone or with a sulfonylurea were assigned to once-weekly BYDUREON 2 mg or once-daily insulin glargine (titrated based on INITIATE algorithm). Of the 456 randomized patients, 287 completed 3 years of treatment. Patient demographics (mITT): BYDUREON: 52% male, 82% Caucasian; FPG, 178.2 mg/dL; duration of diabetes, 8 years (mean); insulin glargine: 55% male, 85% Caucasian; FPG, 174.6 mg/dL; duration of diabetes, 7.8 years (mean).1 Patients in the insulin glargine arm were dosed based on the INITIATE algorithm.3 Concomitant oral glucose lowering therapies were continued at stable doses until at least week 48, after which changes could be made. The following changes were reported (n, [%]): increase in the dose of oral agent: BYDUREON, 47 (20%) and insulin glargine, 14 (6%); addition of insulin (or adding another insulin): BYDUREON, 4 (2%) and insulin glargine, 15 (7%); adding another oral agent: BYDUREON, 27 (12%) and insulin glargine, 16 (7%).1


Once-weekly BYDUREON…

Proven to Provide Powerful and Sustained A1C Reductions Over 3 Years

Mean A1C over 3 years
 
  • BYDUREON (2 mg) QW (n=228, mITT)
  • Insulin glargine (n=220, mITT titrated, average dose @3 years was 39 IU/day, with a range from 9-154 IU/day)
 
  • BYDUREON (2 mg) QW (n=228, mITT)
  • Insulin glargine (n=220, mITT titrated, average dose @3 years was 39 IU/day, with a range from 9-154 IU/day)

The difference in observed effect size between BYDUREON and insulin glargine in this trial excluded the pre-specified non-inferiority margin of 0.3%.

INSULIN TITRATION:

Insulin glargine was titrated based on the INITIATE algorithm, starting at 10 IU/day and adjusted based on clinical judgement targeting an FPG of 72 to 100 mg/dL.1 FPG goal was achieved in 21% of insulin glargine patients at 26 weeks and in 23% at 3 years.1

*BYDUREON is not indicated for weight loss. In a 3-year, randomized, controlled, open-label extension study, BYDUREON patients (baseline of 200.4 lb) observed an average weight reduction of 5.5 lb.1

aFor efficacy measures (A1C, FPG, weight), all randomized patients with at least 1 post‑baseline measurement were included in the analysis.

bBackground therapy (percentage of patients): metformin alone, 70%; metformin plus sulfonylurea, 30% (both arms). Background oral therapies were continued at stable doses until at least week 48, after which changes could be made based on clinical need.

cP <.001 compared with baseline.5,6

Abbreviations: FPG, fasting plasma glucose; LS, least squares; mITT, modified intent-to-treat; QW, once weekly.


Once-weekly BYDUREON…

Proven to Provide Sustained Weight Loss Over 3 Years

BYDUREON is not indicated for weight loss. In a 3-year, randomized, controlled, open-label extension study, BYDUREON patients (baseline of 200.4 lb) observed an average weight reduction of 5.5 lb.1

BYDUREON is not indicated for weight loss. In a 3-year, randomized, controlled, open-label extension study, BYDUREON patients (baseline of 200.4 lb) observed an average weight reduction of 5.5 lb.1

Mean change in body weight over 3 years
Mean change in body weight over 3 years
Mean change in body weight over 3 years
  • BYDUREON (2 mg) QW (n=233, mITT)
  • Insulin glargine (n=222, mITT titrated, average dose @3 years was 39 IU/day, with a range from 9-154 IU/day)
  • BYDUREON (2 mg) QW (n=233, mITT)
  • Insulin glargine (n=222, mITT titrated, average dose @3 years was 39 IU/day, with a range from 9-154 IU/day)

*BYDUREON is not indicated for weight loss. In a 3-year, randomized, controlled, open-label extension study, BYDUREON patients (baseline of 200.4 lb) observed an average weight reduction of 5.5 lb.1

aFor efficacy measures (A1C, FPG, weight), all randomized patients with at least 1 post‑baseline measurement were included in the analysis.

bP <.001 compared with baseline.

Abbreviations: FPG, fasting plasma glucose; LS, least square; mITT, modified intent-to-treat; QW, once weekly.

BYDUREON Pen

Designed to be patient-friendly.

BYDUREON Pen

Designed to be patient-friendly.

Multiple glycemic effects in the body.

GLP-1 RA Therapy

Multiple effects of GLP-1 in the body.

GLP-1 RA Therapy

Multiple effects of GLP-1 in the body.