A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT01358929

Run by

Hoffmann-La Roche

People needed

45

Starts

2011-04-01

Expected to finish

2011-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Chula Vista, California, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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