Back to resultsA Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
taspoglutide
taspoglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Tmax, log (AUC), log(Cmax)of paracetamol
Secondary Outcome Measures
Adverse events, laboratory parameters, vital signs
renal function (creatinine clearance, urine volume and electrolytes)
Multiple dose pharmacokinetics of Taspoglutide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00809705
Brief Title
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sc once weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
taspoglutide
Intervention Description
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
Intervention Type
Drug
Intervention Name(s)
taspoglutide
Intervention Description
10mg sc once weekly for 12 weeks
Primary Outcome Measure Information:
Title
Tmax, log (AUC), log(Cmax)of paracetamol
Time Frame
Days -1, 1, 5, 29, 33, 78 and 82
Secondary Outcome Measure Information:
Title
Adverse events, laboratory parameters, vital signs
Time Frame
Throughout study
Title
renal function (creatinine clearance, urine volume and electrolytes)
Time Frame
Throughout study
Title
Multiple dose pharmacokinetics of Taspoglutide
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
14050
Country
Germany
City
Neuss
ZIP/Postal Code
41460
Country
Germany
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
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