- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951183
A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin
November 1, 2016 updated by: Hoffmann-La Roche
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults between the age of 18 and 65
- Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
- Hemoglobin A1c between 7.2 and 10.5%
- Fasting plasma glucose less than 250 mg/dL
- C-peptide greater than 1.5 ng/mL
- Body mass index (BMI) between 27 and 44
Exclusion Criteria:
- Pregnant or lactating women
- Type 1 diabetes
- Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
- Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
- Significant kidney or liver disease as determined by the investigator
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
RO681135 placebo subcutaneously daily
|
EXPERIMENTAL: RO6811135
|
Subcutaneously daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in HbA1c
Time Frame: from baseline to Week 12
|
from baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in fasting plasma glucose (FPG)
Time Frame: from baseline to Week 12
|
from baseline to Week 12
|
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame: 12 weeks
|
12 weeks
|
Safety: Incidence of adverse events
Time Frame: 19 weeks
|
19 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
December 1, 2013
Primary Completion (ANTICIPATED)
December 1, 2013
Study Completion (ANTICIPATED)
December 1, 2013
Study Registration Dates
First Submitted
September 23, 2013
First Submitted That Met QC Criteria
September 23, 2013
First Posted (ESTIMATE)
September 26, 2013
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
- NP29013
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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