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
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Nov 2011
Shorter than P25 for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedNovember 2, 2016
November 1, 2016
2 months
January 12, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in hemoglobin A1c (HA1c)
Baseline and 12 weeks
Secondary Outcomes (2)
Change in fasting plasma glucose
Baseline and 12 weeks
Safety (incidence of adverse events)
12 weeks
Study Arms (4)
Liraglutide Arm
EXPERIMENTALPlacebo Arm
PLACEBO COMPARATORRO6807952 Arm 1
EXPERIMENTALRO6807952 Arm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Cincinnati, Ohio, 45227, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2012
First Posted
January 24, 2012
Study Start
November 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11