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 |
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.
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
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