A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: RO6807952; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358929

BP25742

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RO6807952

2

Placebo Comparator group

Treatment:

Drug: Placebo