A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:8/3/2016
Start Date:March 2013
End Date:September 2013

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics 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
- Hemoglobin A1c (HbA1c) levels at screening >/= 6.5% and
- 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
We found this trial at
2
sites
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials