A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

• Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
• renal function (creatinine clearance, urine volume and electrolytes) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
• Multiple dose pharmacokinetics of Taspoglutide [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

• Drug: taspoglutide
  10mg sc once weekly for 12 weeks
• Drug: taspoglutide
  10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
• Drug: Placebo
  sc once weekly for 12 weeks

• Experimental: 1
  Intervention: Drug: taspoglutide
• Experimental: 2
  Intervention: Drug: taspoglutide
• Placebo Comparator: 3
  Intervention: Drug: Placebo

Inclusion Criteria:

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
• stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

• type 1 diabetes mellitus;
• acute gastrointestinal symptoms at screening and/or day -1;
• clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.