- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516476
Study of RO6807952 in Patients With Diabetes Mellitus Type 2
November 1, 2016 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45227
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Arm
|
Placebo for 12 weeks
|
Experimental: Liraglutide Arm
|
liraglutide for 12 weeks
|
Experimental: RO6807952 Arm 1
|
multiple doses for 12 weeks
|
Experimental: RO6807952 Arm 2
|
multiple doses for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hemoglobin A1c (HA1c)
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety (incidence of adverse events)
Time Frame: 12 weeks
|
12 weeks
|
Change in fasting plasma glucose
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
January 12, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 24, 2012
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP27804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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