A Study of RO6807952 in Patients With Diabetes Mellitus Type 2



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:8/3/2016
Start Date:April 2011
End Date:September 2011

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A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients

This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive
multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is
8 weeks.


Inclusion Criteria:

- Adult patients, 18 to 70 years of age, inclusive

- Diagnosis of type 2 diabetes >/=3 months and
- Fasting plasma glucose >/=110 mg/dL and
- Patients on a stable dose of metformin for at least 2 months prior to screening

- Hemoglobin HbA1c >/=6.5% and
- Body mass index >/=25 kg/m2 and
- Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg

Exclusion Criteria:

- Patients with type 1 diabetes

- History of significant renal and hepatic diseases

- History of metabolic acidosis and diabetic gastroparesis

- History of pancreatitis

- History of coagulation disorders or unexplained excessive bleeding

- History of clinically significant cardiovascular disease or severe symptomatic
hypoglycemia within 6 months of screening
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