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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00717457
Registration number
NCT00717457
Ethics application status
Date submitted
16/07/2008
Date registered
17/07/2008
Date last updated
2/11/2016
Titles & IDs
Public title
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
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Scientific title
Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
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Secondary ID [1]
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2008-001856-36
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Secondary ID [2]
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BC21625
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2
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Condition category
Condition code
Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - exenatide
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide
Active comparator: exenatide -
Experimental: taspoglutide 10mg -
Experimental: taspoglutide 10mg/20mg -
Treatment: Drugs: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
Treatment: Drugs: taspoglutide
10mg once weekly
Treatment: Drugs: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in HbA1c
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Assessment method [1]
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0
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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Fasting body weight
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Assessment method [1]
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0
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
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Assessment method [2]
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0
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
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Assessment method [3]
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0
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Timepoint [3]
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24 weeks
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Secondary outcome [4]
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Beta cell function (proinsulin/insulin ratio)
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Assessment method [4]
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0
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Timepoint [4]
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24 weeks
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Eligibility
Key inclusion criteria
* adult patients, 18-75 years of age;
* type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
* HbA1c >=7.0% and <=10% at screening;
* BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
* stable weight +/- 5% for at least 12 weeks prior to screening.
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Minimum age
18
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
* history of acute metabolic diabetic complications within the previous 6 months;
* evidence of clinically significant diabetic complications;
* known proliferative diabetic retinopathy;
* myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
* any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
* known hemoglobinopathy or chronic anemia;
* clinically significant gastrointestinal disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2011
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Sample size
Target
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Accrual to date
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Final
1189
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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- Camperdown
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- Freemantle
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2050 - Camperdown
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Recruitment postcode(s) [2]
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6959 - Freemantle
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Trowbridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00717457
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Trial related presentations / publications
Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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https://clinicaltrials.gov/study/NCT00717457
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