First Reported Head-to-Head Study Showed BYETTA(R) (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than Januvia(TM) (sitagliptin) in Patients With Type 2 Diabetes

Tuesday, September 9, 2008 General News
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ROME, Sept. 9 Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced resultsfrom a randomized, double-blind, cross-over, four-week head-to-head studydemonstrating that BYETTA(R) (exenatide) injection, a GLP-1 receptor agonist,provided significantly lower glucose levels in the post-meal setting whencompared to Januvia(TM) (sitagliptin), a DPP-4 inhibitor. Additionally,patients treated with BYETTA reduced post-meal glucagon, showed more efficientuse of their body's own insulin and decreased their food intake when comparedto Januvia. This is the first reported head-to-head study directly comparingthe therapeutic mechanisms of action (MOA) of BYETTA and Januvia. The findingswere presented at the 44th Annual Meeting of the European Association for theStudy of Diabetes (EASD) in Rome, Italy. The study will also be published inthe peer-reviewed journal, Current Medical Research and Opinion.

"There has been some confusion in the marketplace about the therapeuticdifferences between BYETTA and Januvia, and data from this first head-to-headstudy showed a clear difference in the MOAs and resultant short-term clinicaleffects between these two agents. BYETTA works directly on the GLP-1 receptor,whereas Januvia indirectly affects GLP-1 levels," said Ralph DeFronzo, M.D.,professor of medicine and chief of the Diabetes Division at the University ofTexas Health Science Center in San Antonio and a clinical trial investigatoron this study. "Patients on BYETTA experienced significantly lower post-mealglucose levels, improved measures of beta cell function and decreased foodintake."

The primary endpoint of this four-week study compared the effect of BYETTAand Januvia on 2-hour post-meal glucose. Secondary endpoints includedpost-meal glucagon, insulin secretion rate, gastric emptying, and food intake.Patients were randomly assigned to treatment with either BYETTA (5 mcg twicedaily for the first week followed by 10 mcg twice daily for the second week)or Januvia (100 mg once daily) for two weeks; patients were then switched tothe alternate therapy for the remaining two weeks. At baseline and at the endof each two week treatment period, patients underwent a standard meal test andother evaluations to assess each drug's effects on various measures ofpost-meal glucose control, indicators of beta cell function and otherparameters.

Study Findings

In response to a standard meal, patients (evaluable population, N=61)treated with BYETTA had significantly improved post-meal glucose levels twohours after the standard meal when compared to Januvia (133 mg/dL vs. 208mg/dL at 2 hours respectively, baseline: 245 mg/dL; P<0.0001). Differences inpost-meal glucose levels for the intent-to-treat (ITT) population (N=95) alsoshowed significantly lower post-meal glucose levels with BYETTA compared toJanuvia (166 mg/dL vs. 210 mg/dL respectively; P<0.0001). As patients wereswitched from Januvia to BYETTA after two weeks, the post-meal glucose wasfurther improved (-76 mg/dL), while patients who switched from BYETTA toJanuvia partially lost the post-meal glucose (+73 mg/dL) control achieved withBYETTA.

The study also showed that after two weeks of treatment both BYETTA andJanuvia improved fasting plasma glucose (FPG) (-15 mg/dL and -19 mg/dLrespectively, baseline: 178 mg/dL). BYETTA significantly improved an indicatorof beta cell function, the insulinogenic index of insulin secretion comparedto Januvia (ratio: 1.50 +/- 0.26, P=0.0239). BYETTA also reduced elevatedpost-meal glucagon (ratio AUC: 0.88 +/- 0.03, P=0.0011) to a greater extentthan Januvia and slowed gastric emptying (ratio AUC: 0.56 +/- 0.05, P<0.0001).BYETTA reduced food intake compared to Januvia during buffet-style meals (-134kcal vs. +130 kcal, P=0.0227), and patients treated with BYETTA experienced agreater reduction in post-meal triglyceride concentrations compared to

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