Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Primary Purpose
Diabetes Mellitus Type 2
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
RO6807952
RO6807952
liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Liraglutide Arm
Placebo Arm
RO6807952 Arm 1
RO6807952 Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Change in hemoglobin A1c (HA1c)
Secondary Outcome Measures
Change in fasting plasma glucose
Safety (incidence of adverse events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01516476
Brief Title
Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide Arm
Arm Type
Experimental
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Title
RO6807952 Arm 1
Arm Type
Experimental
Arm Title
RO6807952 Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RO6807952
Intervention Description
multiple doses for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RO6807952
Intervention Description
multiple doses for 12 weeks
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
liraglutide for 12 weeks
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c (HA1c)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in fasting plasma glucose
Time Frame
Baseline and 12 weeks
Title
Safety (incidence of adverse events)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of RO6807952 in Patients With Diabetes Mellitus Type 2
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