Diabetes Mellitus Type 2
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Matching placebo, multiple doses
DRUGRO6811135
multiple ascending doses
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | approximately 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Day 1 and Day 14 |
| Pharmacodynamics of RO681135: Blood analysis | 14 days |
Countries
United States
Outcome results
None listed