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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/NCT00909597




Registration number
NCT00909597
Ethics application status
Date submitted
27/05/2009
Date registered
28/05/2009
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
Scientific title
A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea
Secondary ID [1] 0 0
2009-009157-24
Secondary ID [2] 0 0
BC21893
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 - pioglitazone
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide

Active Comparator: pioglitazone -

Experimental: taspoglutide 10mg - taspoglutide 10mg sc weekly

Experimental: taspoglutide 10mg/20mg - taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly


Treatment: Drugs: pioglitazone
30mg po once daily for 4 weeks, followed by 45mg once daily

Treatment: Drugs: taspoglutide
10mg sc once weekly

Treatment: Drugs: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in HbA1c
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Proportion of patients achieving target HbA1c <=6.5%, <=7%
Timepoint [1] 0 0
weeks 24, 52 and 104
Secondary outcome [2] 0 0
Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose
Timepoint [2] 0 0
weeks 24, 52 and 104
Secondary outcome [3] 0 0
Adverse events; laboratory parameters; cardiovascular events
Timepoint [3] 0 0
At each clinic visit up to 106 weeks

Eligibility
Key inclusion criteria
- adult patients, 18-75 years of age;

- type 2 diabetes mellitus;

- treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12
weeks prior to screening;

- HbA1c >=7.0% and <=10% at screening;

- stable weight +/-5% for >=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
- type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of
diabetes;

- clinically significant diabetic complications;

- clinically symptomatic gastrointestinal disease;

- >3 episodes of severe hypoglycemia within 6 months before screening.

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
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
756
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment outside Australia
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United States of America
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California
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Florida
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Wisconsin
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CE
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Ontario
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Besancon
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Rodgau
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Siegen
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Wangen
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Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and
tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus
inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin
combination therapy. After an initial screening period, patients will be randomized to one of
3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4
weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of
pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target
sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00909597
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/NCT00909597