- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961909
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
November 1, 2016 updated by: Hoffmann-La Roche
A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus.
Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 1
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
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California
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Anaheim, California, United States, 92801
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Chula Vista, California, United States, 91911
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Florida
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Ft. Myers, Florida, United States, 33901
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Miramar, Florida, United States, 33025
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Texas
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San Antonio, Texas, United States, 78209
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San Antonio, Texas, United States, 78229-4801
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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:
- adult patients, 18-65 years of age
- females who are either surgically sterile or post-menopausal
- type 2 diabetes treated with a stable dose of metformin
- BMI between 25-39kg/m2
- HbA1c between 7 and 10%
- fasting plasma glucose between 7 and 13.3mmol/L
Exclusion Criteria:
- history of clinically significant cardiovascular disease
- history of clinically significant hepatic or renal disease or impairment
- recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors
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
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1active
|
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
dose titration to target dose, sc once weekly for 6 weeks
stable dose
|
Placebo Comparator: 1placebo
|
stable dose
sc once weekly for 4 weeks
|
Experimental: 2active
|
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
dose titration to target dose, sc once weekly for 6 weeks
stable dose
|
Placebo Comparator: 2placebo
|
stable dose
sc once weekly for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
Time Frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
|
monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
|
Change in hemoglobin A1c (HbA1c)
Time Frame: from baseline to week 6
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from baseline to week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: blood concentration of RO5095932 after multiple dosing
Time Frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
|
multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
|
Change in metabolic parameters: glucose, insulin, C-peptide
Time Frame: assessed after 4 or 6 weeks on study treatment
|
assessed after 4 or 6 weeks on study treatment
|
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
June 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
August 18, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
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
- NP22340
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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