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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.
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
Secondary ID [1] 0 0
2008-001856-36
Secondary ID [2] 0 0
BC21625
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Fasting body weight
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Beta cell function (proinsulin/insulin ratio)
Timepoint [4] 0 0
24 weeks

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
1189
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Freemantle
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
6959 - Freemantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00717457
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00717457