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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01018173




Trial ID
NCT01018173
Ethics application status
Date submitted
20/11/2009
Date registered
20/11/2009
Date last updated
1/11/2016

Titles & IDs
Public title
A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
Scientific title
A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease
Secondary ID [1] 0 0
2009-014986-22
Secondary ID [2] 0 0
NC25113
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 - placebo
Treatment: Drugs - taspoglutide

Placebo Comparator: placebo -

Experimental: taspoglutide -


Treatment: Drugs: placebo
sc weekly

Treatment: Drugs: taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to cardiovascular composite primary endpoints
Timepoint [1] 0 0
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Secondary outcome [1] 0 0
Secondary cardiovascular composite endpoints
Timepoint [1] 0 0
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Secondary outcome [2] 0 0
Individual components of primary cardiovascular composite endpoints
Timepoint [2] 0 0
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Secondary outcome [3] 0 0
Total mortality
Timepoint [3] 0 0
assessed at end of study, week 104
Secondary outcome [4] 0 0
Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR)
Timepoint [4] 0 0
laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter

Eligibility
Key inclusion criteria
- adult patients, >18 years of age

- diabetes mellitus type 2

- HbA1c >/=6.5% and </=10% at screening

- BMI >/=23kg/m2

- cardiovascular disease with onset >/=1 month prior to screening
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- diagnosis or history of type 1 diabetes or secondary forms of diabetes

- acute metabolic diabetic complications within past 6 months

- severe hypoglycemia </=1 month prior to screening

- clinically significant gastrointestinal disease

- history of chronic or acute pancreatitis

- current New York Heart Association (NYHA) class IV heart failure or
post-transplantation cardiomyopathy

- severely impaired renal function

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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- Freemantle
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- Herston
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- Elizabeth Vale
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- Melbourne
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6959 - Freemantle
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
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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 randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and
safety and the effects of taspoglutide on cardiovascular events in patients with inadequately
controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be
randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks
followed by 20mg sc weekly, or weekly sc placebo, in addition to background
anti-hyperglycemic medication and standard of care treatment for cardiovascular disease.
Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.
Trial website
https://clinicaltrials.gov/show/NCT01018173
Trial related presentations / publications
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