This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Condition	Treatment or Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide	Phase III

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

Criteria

Main Inclusion Criteria:

• Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
• HbA1c between 7.1% and 11.0%, inclusive.
• Insulin therapy should be the next appropriate step of diabetes treatment.
• Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main Exclusion Criteria:

• Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
• Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

Australia, New South Wales
      Research Site, Westmead,  New South Wales,  Australia; Recruiting
Australia, South Australia
      Research Site, Fullarton,  South Australia,  Australia; Recruiting
      Research Site, Daw Park,  South Australia,  Australia; Recruiting
Australia, Victoria
      Research Site, Box Hill,  Victoria,  Australia; Recruiting
      Research Site, East Ringwood,  Victoria,  Australia; Recruiting
Greece
      Research Site, Athens,  Greece; Recruiting
      Research Site, THESSALONIKI,  Greece; Recruiting
      Research Site, Piraeus,  Greece; Recruiting
Hungary
      Research Site, Zalaegerszeg,  Hungary; Recruiting
      Research Site, Veszprem,  Hungary; Recruiting
      Research Site, Budapest,  Hungary; Recruiting
      Research Site, Pecs,  Hungary; Recruiting
      Research Site, Gyula,  Hungary; Recruiting
Italy
      Research Site, Milan,  Italy; Recruiting
      Research Site, Perugia,  Italy; Recruiting
      Research Site, Bari,  Italy; Recruiting
      Research Site, Rome,  Italy; Recruiting
      Research Site, Catania,  Italy; Recruiting
      Research Site, Bergamo,  Italy; Recruiting
Mexico
      Research Site, Mexico City,  Mexico; Recruiting
Mexico, Jalisco
      Research Site, Guadalajara,  Jalisco,  Mexico; Recruiting
      Research Site, Zapopan,  Jalisco,  Mexico; Recruiting
Mexico, N.L.
      Research Site, Monterrey,  N.L.,  Mexico; Recruiting
Poland
      Research Site, Lublin,  Poland; Recruiting
      Research Site, Bydgoszcz,  Poland; Recruiting
      Research Site, Gdansk,  Poland; Recruiting

Study ID Numbers:  H8O-MC-GWAO
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  December 17, 2004
ClinicalTrials.gov Identifier:  NCT00099619
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08