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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00909597




Registration number
NCT00909597
Ethics application status
Date submitted
27/05/2009
Date registered
27/05/2009
Date last updated
1/11/2016

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
Diabetes Mellitus Type 2 0 0
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
Treatment: Drugs - pioglitazone
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide
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

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

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

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

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
Primary outcome [2] 0 0
Absolute change from baseline in HbA1c
Timepoint [2] 0 0
24 weeks
Primary outcome [3] 0 0
Absolute change from baseline in HbA1c
Timepoint [3] 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
Secondary outcome [4] 0 0
Proportion of patients achieving target HbA1c <=6.5%, <=7%
Timepoint [4] 0 0
weeks 24, 52 and 104
Secondary outcome [5] 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 [5] 0 0
weeks 24, 52 and 104
Secondary outcome [6] 0 0
Adverse events; laboratory parameters; cardiovascular events
Timepoint [6] 0 0
At each clinic visit up to 106 weeks
Secondary outcome [7] 0 0
Proportion of patients achieving target HbA1c <=6.5%, <=7%
Timepoint [7] 0 0
weeks 24, 52 and 104
Secondary outcome [8] 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 [8] 0 0
weeks 24, 52 and 104
Secondary outcome [9] 0 0
Adverse events; laboratory parameters; cardiovascular events
Timepoint [9] 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
Gender
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
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)
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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Nebraska
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New Jersey
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New York
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North Carolina
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North Dakota
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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State/province [25] 0 0
Washington
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United States of America
State/province [26] 0 0
Wisconsin
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Brazil
State/province [27] 0 0
CE
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Brazil
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DF
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Brazil
State/province [29] 0 0
MG
Country [30] 0 0
Brazil
State/province [30] 0 0
SP
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
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Costa Rica
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San Jose
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France
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Besancon
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France
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Corbeil Essonnes
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France
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Dommartin Les Toul
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La Rochelle
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Lille
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Poitiers
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France
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Venissieux
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Germany
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Berlin
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Germany
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Essen
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Germany
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Falkensee
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Germany
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Mainz
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Germany
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Münster
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Germany
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Rodgau
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Germany
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Siegen
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Germany
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Sulzbach-Rosenberg
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Germany
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Wangen
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Aguascaliente
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Rio Piedras
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Russian Federation
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Moscow
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Russian Federation
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Penza
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Russian Federation
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S.Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Voronezh
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Russian Federation
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Yaroslavl
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Slovakia
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Bratislava
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Slovakia
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Dolny Kubin
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Levice
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South Africa
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Cape Town
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Spain
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Asturias
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Spain
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Navarra
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Vizcaya
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Barcelona
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Chiang Mai
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Thailand
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Songkla
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Ukraine
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Kiev
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Odessa
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Ukraine
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Vinnitsa
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United Kingdom
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Atherstone
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Birmingham
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Chesterfield
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Dumfries
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Glasgow
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Hinckley
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United Kingdom
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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/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
Other publications