A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
This randomized, double-blind, placebo-controlled, multiple ascending dose study will
 evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in
 patients with type 2 diabetes mellitus. Patients will be randomized to receive either
 RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the
 last dose of study drug.
Inclusion Criteria:

 -  Adult patients, 18 to 65 years of age, inclusive

 -  Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months
 prior to screening

 -  On stable dose of metformin for at least 2 months prior to screening

 -  Fasting plasma glucose during the screening period </= 240 mg/dL

 -  Hemoglobin A1c (HbA1c) levels at screening >/= 6.5% and </= 10.5%

 -  Evidence of insulin secretory capacity at screening

 -  Body mass index (BMI) 27 to 42 kg/m2, inclusive

 -  Females of child-bearing potential and males with female partners of child-bearing
 potential must agree to use effective contraception as defined by protocol

 Exclusion Criteria:

 -  Type 1 diabetes

 -  Acquired or secondary forms of diabetes such as those resulting from pancreatic
 surgery/injury, cystic fibrosis related diabetes

 -  History of acute metabolic complications such as diabetic ketoacidosis or state of
 hyperosmolar hyperglycemia

 -  Evidence or history of clinically significant diabetic complications such as
 clinically severe diabetic peripheral neuropathy, clinically significant nephropathy
 as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy
 as judged by the investigator

 -  History of severe symptomatic hypoglycemia (requiring assistances of a third party)
 within 6 months prior to screening

 -  History or presence of clinically significant concomitant disease or disorder

 -  Hemoglobin level below the lower limit of reference range at screening

 -  Pregnant or lactating women

 -  History of anaphylaxis or severe systemic hypersensitivity or allergic reactions