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 |
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.
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 =10 years prior to screening
- Fasting plasma glucose >/=110 mg/dL and =240 mg/dL
- Patients on a stable dose of metformin for at least 2 months prior to screening
- Hemoglobin HbA1c >/=6.5% and =10.5%
- Body mass index >/=25 kg/m2 and =42 kg/m2
- 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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