Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Roche

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: liraglutide; Drug: Placebo; Drug: RO6807952

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516476

BP27804

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

Enrollment: 2 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients >/= 18 and </=70 years of age
• Diagnosis of diabetes mellitus, type 2 for at least 3 months
• Treated with a stable dose of metformin
• Hemoglobin A1c >/=7.0% and </=10.5% at screening
• Fasting plasma glucose </=240 mg/dL at screening
• Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening
• Willing and able to maintain existing diet and exercise habits throughout the study
• C-peptide >1.5 ng/mL at screening

Exclusion criteria

• History of significant liver or kidney disease
• History of uncontrolled hypertension
• History of significant cardiovascular disease
• History of significant diabetic complications
• History of significant gastrointestinal conditions
• History of weight loss surgery or procedures involving the gastrointestinal tract
• History of chronic or acute pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 4 patient groups, including a placebo group

Liraglutide Arm

Experimental group

Treatment:

Drug: liraglutide

Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

RO6807952 Arm 1

Experimental group

Treatment:

Drug: RO6807952

Drug: RO6807952

RO6807952 Arm 2

Experimental group

Treatment:

Drug: RO6807952

Drug: RO6807952