- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00682097
A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.
November 1, 2016 updated by: Hoffmann-La Roche
A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus.
Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo.
The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
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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-
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Neuss, Germany, 41460
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-
-
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California
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Chula Vista, California, United States, 91911
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Texas
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San Antonio, Texas, United States, 78229
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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;
- type 2 diabetes;
- either treated by diet and exercise alone or with metformin.
Exclusion Criteria:
- type 1 diabetes mellitus;
- uncontrolled hypertension;
- clinically severe diabetic complications.
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 |
---|---|
Experimental: 1
|
Escalating oral doses
Oral doses
|
Experimental: 2
|
Escalating oral doses
Oral doses
|
Experimental: 3
|
Escalating oral doses
Oral doses
|
Experimental: 4
|
Escalating oral doses
Oral doses
|
Experimental: 5
|
Escalating oral doses
Oral doses
|
Experimental: 6
|
Escalating oral doses
Oral doses
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Experimental: 7
|
Escalating oral doses
Oral doses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AEs, laboratory parameters, vital signs.
Time Frame: Throughout study
|
Throughout study
|
AUC0-24h, Cmax
Time Frame: Days 1 and 14
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Days 1 and 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parameters of glucose metabolism
Time Frame: Throughout study
|
Throughout study
|
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
May 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 20, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (Estimate)
May 22, 2008
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
- BP21549
- 2007-007120-18
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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