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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01018173




Registration number
NCT01018173
Ethics application status
Date submitted
20/11/2009
Date registered
23/11/2009
Date last updated
2/11/2016

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
Sex
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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
2118
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01018173