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<title>Table 1</title><table>
  <tr>
    <td><table border="1" cellspacing="0" cellpadding="0" >
      <tr>
        <td width="147" bgcolor="#999999"><strong><em>Study     No. 
          (ClinicalTrials.gov identifier) [Ref. for details]</em></strong></td>
        <td width="99" bgcolor="#999999"><strong>Subjects 
          (n [% male])</strong></td>
        <td width="143" bgcolor="#999999"><strong>Study     population</strong></td>
        <td width="128" bgcolor="#999999"><strong>Design</strong></td>
        <td width="109" bgcolor="#999999"><strong>Dosing<sup>a</sup></strong></td>
        <td width="117" bgcolor="#999999"><strong>Pharmacokinetic     sampling times</strong></td>
        <td width="91" bgcolor="#999999"><strong>Age (y)<sup>b</sup></strong></td>
        <td width="98" bgcolor="#999999"><strong>Body     weight (kg)<sup>b,c</sup></strong></td>
      </tr>
      <tr>
        <td colspan="8"><em>Phase 1 studies</em><em>&nbsp;</em><em>&nbsp;</em><em>&nbsp;</em></td>
        </tr>
      <tr>
        <td width="147">BDR6864</td>
        <td width="99">43 [65.1]</td>
        <td width="143">Overweight and obese, otherwise healthy</td>
        <td width="128">Randomized, open-label, three-way crossover;    injections at different sites: arm, thigh, and abdomen (reference) </td>
        <td width="109">Single, 10 &micro;g</td>
        <td width="117">Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8,    12, 16, and 24 h after administration</td>
        <td width="91">39.4&plusmn;10.8 (20-64)</td>
        <td width="98">94.0&plusmn;10.9 (71.3-117)</td>
      </tr>
      <tr>
        <td width="147">POP6053</td>
        <td width="99">32 [68.8]</td>
        <td width="143">Healthy with either normal renal function    (creatinine clearance, CL<sub>CR</sub>, &gt; 80 ml/min [&gt;4.8 l/h]) or mild    (CL<sub>CR</sub>= 50-80 ml/min [3-4.8 l/h]), moderate (CL<sub>CR</sub> =    30-50 ml/min [1.8-3 l/h]), or severe renal impairment (CL<sub>CR</sub> &lt;30    ml/min [&lt;1.8l/h])</td>
        <td width="128">Non-randomized, parallel-group study</td>
        <td width="109">Single, 5 &micro;g</td>
        <td width="117">Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5,    6, 7, 8, 10, 12, 15, 24, 36, 48, and 72h after administration</td>
        <td width="91">59.1&plusmn;11.2 (36-74)</td>
        <td width="98">80.1&plusmn;12.9 (61-105)</td>
      </tr>
      <tr>
        <td colspan="8"><em>Phase 2 studies</em> </td>
        </tr>
      <tr>
        <td width="147">PDY6797</td>
        <td width="99">79 [74.7]</td>
        <td width="143">T2DM<sup>d</sup></td>
        <td width="128">Multinational, randomized, double-blind,    parallel-group study</td>
        <td width="109">Single, 5 or 10 &mu;g, and multiple, QD or BID, up to    30 &mu;g for 6 weeks. Starting dose: 5 or 10 &mu;g,    to be increased in weekly increments of 5 &mu;g (placebo-controlled)</td>
        <td width="117">Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3.5, 4.5, 6.5,    10, 12.5, and 24 h in the single-dose phase and at pre-dose and 0.5, 1, 1.5,    2, 2.5, 3.5, 4.5, 6.5, and 10 h post-morning injection, and 2.5 h    post-evening injection, in the repeated-dose phase<sup>e</sup></td>
        <td width="91">62.0&plusmn;7.6 (44-75)</td>
        <td width="98">74.7&plusmn;17.1 (46.2-120)</td>
      </tr>
      <tr>
        <td width="147">DRI6012    (NCT00299871)</td>
        <td width="99">349 [48.4]</td>
        <td width="143">T2DM</td>
        <td width="128">Multinational, randomized, double-blind,    placebo-controlled, dose-response trial</td>
        <td width="109">Multiple, QD or BID 5, 10, 20, or 30 &mu;g for 13    weeks. For dose levels 20 and 30 &mu;g: starting dose: 10 &mu;g, to be increased in    weekly increments of 5 &mu;g (placebo-controlled)</td>
        <td width="117">At least 1 blood sample from each participant after    13 weeks. In about 50% of the participants, at pre-dose and 0.5, 1, 1.5, 2.5,    3.5, and 4.5h after 13 weeks of treatment</td>
        <td width="91">57.3&plusmn;8.4 
          (31-75)</td>
        <td width="98">87.6&plusmn;15.4 (52.4-133)</td>
      </tr>
      <tr>
        <td colspan="8"><em>Phase 3 studies</em> </td>
        </tr>
      <tr>
        <td width="147">EFC6018    (NCT00688701) [21]</td>
        <td width="99">184 [53.8]</td>
        <td width="143">T2DM</td>
        <td width="128">Multinational, randomized, double-blind, 3 months    study</td>
        <td width="109">Multiple, QD, 1 week at 10 &mu;g, 1 week at 15 &mu;g, and    10 weeks at 20 &mu;g (12 weeks total) or multiple, QD, 2 weeks at 10 &mu;g and 10    weeks at 20 &mu;g (12 weeks total, placebo-controlled)</td>
        <td width="117">A total of &ge; 6 samples were drawn from each    participant, namely 2 (before and 1 to 4 hours after dosing) at 2, 4 and 12    weeks of treatment, or, additionally, when ever an unscheduled event    occurred.</td>
        <td width="91">53.5&plusmn;10.2 (20-82)</td>
        <td width="98">59.5&plusmn;21.8 (44.5-160)</td>
      </tr>
      <tr>
        <td width="147">EFC10887    (NCT00866658) [22]</td>
        <td width="99">135 [43.7]</td>
        <td width="143">Asian T2DM</td>
        <td width="128">Randomized, double-blind, placebo-controlled, parallel-group,    multicentre study</td>
        <td width="109">Multiple, QD, 1 week at 10 &mu;g, 1 week at 15 &mu;g, and    22 weeks at 20 &mu;g (24 weeks total, placebo-controlled)</td>
        <td width="117">A total of &ge; 6 samples were drawn from each    participant, namely 3 (before, 1 to 2 hours, and 4 to 6 h after dosing) at 2,    and 24 weeks of treatment, or, additionally, when ever an unscheduled event    occurred</td>
        <td width="91">58.7&plusmn;10.5 (25-81)</td>
        <td width="98">65.7&plusmn;13.0 (43.8-119)</td>
      </tr>
      <tr>
        <td width="147">EFC6015    (NCT00713830)</td>
        <td width="99">401 [53.1]</td>
        <td width="143">T2DM</td>
        <td width="128">Randomized, double-blind, placebo-controlled study</td>
        <td width="109">Multiple, QD, 1 week at 10 &mu;g, 1 week at 15 &mu;g, and    22 weeks at 20 &mu;g (24 weeks total double-blind period), followed by variable    extension period up to week 76 (placebo-controlled)</td>
        <td width="117">1 pre-dose and 1 post-dose sample at week 2, 24, 76,    100, each, and at end-of-treatment visit if occurring before week 76</td>
        <td width="91">56.9&plusmn;9.9 
          (25-79)</td>
        <td width="98">83.9&plusmn;21.8 (45.7-163)</td>
      </tr>
      <tr>
        <td width="147"><em>All participants</em> </td>
        <td width="99">1223 [53.1]</td>
        <td width="143">&nbsp;</td>
        <td width="128">&nbsp;</td>
        <td width="109">&nbsp;</td>
        <td width="117">&nbsp;</td>
        <td width="91">56.5&plusmn;10.2 (20-82)</td>
        <td width="98">83.5&plusmn;19.8 (43.8-163)</td>
      </tr>
    </table>
    T2DM, type 2 diabetes mellitus. This table summarizes data of anti-lixisenatide antibody-negative subjects only. Subjects receiving placebo treatment were not taken into account.<br />
      <sup>a</sup> Planned doses per clinical study protocol. The route of administration was subcutaneous.<br />
      <sup>b</sup> Arithmetic mean &plusmn; standard deviation (minimum to maximum).<br />
      <sup>c</sup> In phase 2 and 3 studies, the participants were weighted several times during the study. The first record in the dataset is summarized here.<br />
      <sup>d</sup> Asian and Caucasian patients not adequately controlled with sulfonylurea with or without metformin.<br />
    <sup>e</sup> In the first cohort with a starting dose of 5 &mu;g QD or BID, samples were taken on days 1, 16 &plusmn; 2, 30 &plusmn; 2 and 44 &plusmn; 2. In the second cohort receiving a starting dose of 10 &mu;g QD or BID, samples were taken on days 1, 9 &plusmn; 2, 23 &plusmn; 2 and 37 &plusmn; 2. Patients in the QD group received lixisenatide in the morning and placebo in the evening and patients in the BID group received lixisenatide in the morning and evening. To simplify the inter-occasion variability (IOV) model, all sampling days were renamed using the occasion number from 1 to 4.</td>
  </tr>
  <tr>
    <td><strong>Table 1:</strong> Summary of study data and subject demographics used in the population pharmacokinetic analysis.</td>
  </tr>
</table> 
					
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