ÿþ5 July 2006<br>

VERSION:  1 2 3 4 5 6 7 8 9<br>

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<b>Novo Nordisk</b><br>

<br>

<i>Effects of NovoLog ® Mix 70/30  (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) BID and QD vs. Byetta "! (Exenatide) BID on Glycemic Control:  A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients with Type 2 Diabetes Mellitus not Achieving Glycemic Targets with Metformin and a Sulfonylurea (SU)</i><br>

<br>

Sponsor: Novo Nordisk<br>

Study Drug: NovoLog ® Mix 70/30 <br> 

Protocol: BIAsp 1714<br>	 

Phase IIIB<br>

CRO:<br>  

CRA:<br> 

Site #:<br> 

Investigator #: <br>

Central Lab:<br>  

IRB:<br>  

Subjects 830 Screened -> 540 R/ 125 Sites -> 7 Subjects Screened per Site<br>  

Open Label 3 Arms (180 per Arm):<br>

1.	NovoLog ® Mix 70/30  QD + Metformin + SU<br>

2.	NovoLog ® Mix 70/30  BID + Metformin<br>

3.	Byetta (Exenatide) BID + Metformin + SU<br>

<br>

 IC<br>

18-80<br>

NIDDM for at least 6 months<br>

HbA1C equal/greater than 8.0<br> 

Metformin equal/greater than 1500<br>

SU > half-maximal dose x 3 months before screening<br>

<br>

EC<br>

Insulin Naïve<br>

Creatinine:  Males equal/greater than 1.3 AND Females equal/greater than 1.2<br>

No use x 6 months of: TZD; Glyset; Starlix<br>

Byetta<br>

<br>5 July 2006<br>

VERSION:  1 2 3 4 5 6 7 8 9

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<div align="center">

Novo Nordisk<br>

<div align="left">

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V1 W -2 Lab, Screening Visit, EKG<br>

V2 W  0 R  8-SMBG within 72 H before<br>

V3 W 1<br>   

V4 W 2<br>	  

V5 W 3<br>	 

V6 W 4<br>	 

V7 W 5<br>	 

V8 W 6(P) Lab<br>

V9 W 7<br>   

V10 W 8 Lab<br>  

V11 W 9(P)<br>

V12 W 10(P) Lab<br>

V13 W 11(P)<br>

V14 W 12 Lab, 8-SMBG within 72 H before<br>

V15 W 14(P)<br>

V16 W 15 Lab<br>

V17 W 18(P)<br>

V 18 W 20 Lab<br>

V 19 W 22(P)<br>

V 20 W 24  Lab, EKG, 8-SMBG within 72 H before<br>

V 21 W 26(P)<br>