Study of RO6807952 in Patients With Diabetes Mellitus Type 2

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01516476

Enrollment

Registered

2012-01-24

Start date

2011-11-30

Completion date

2012-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

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.

Interventions

DRUGPlacebo

Placebo for 12 weeks

DRUGRO6807952

multiple doses for 12 weeks

DRUGliraglutide

liraglutide for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin A1c (HA1c)	Baseline and 12 weeks

Secondary

Measure	Time frame
Change in fasting plasma glucose	Baseline and 12 weeks
Safety (incidence of adverse events)	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026