- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809705
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
November 1, 2016 updated by: Hoffmann-La Roche
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes
This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes.
Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study.
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)
60
Phase
- Phase 3
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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Berlin, Germany, 14050
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Neuss, Germany, 41460
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London, United Kingdom, HA1 3UJ
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
- stable weight +/-10% for >=3 months before screening.
Exclusion Criteria:
- type 1 diabetes mellitus;
- acute gastrointestinal symptoms at screening and/or day -1;
- clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.
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
|
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
10mg sc once weekly for 12 weeks
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Experimental: 2
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10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
10mg sc once weekly for 12 weeks
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Placebo Comparator: 3
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sc once weekly for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax, log (AUC), log(Cmax)of paracetamol
Time Frame: Days -1, 1, 5, 29, 33, 78 and 82
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Days -1, 1, 5, 29, 33, 78 and 82
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events, laboratory parameters, vital signs
Time Frame: Throughout study
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Throughout study
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renal function (creatinine clearance, urine volume and electrolytes)
Time Frame: Throughout study
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Throughout study
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Multiple dose pharmacokinetics of Taspoglutide
Time Frame: Throughout study
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Throughout study
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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, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 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
- BP21572
- 2008-003575-47
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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