Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
North Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Brazil
State/province [32] 0 0
GO
Country [33] 0 0
Brazil
State/province [33] 0 0
PA
Country [34] 0 0
Brazil
State/province [34] 0 0
PR
Country [35] 0 0
Brazil
State/province [35] 0 0
RS
Country [36] 0 0
Brazil
State/province [36] 0 0
SP
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Denmark
State/province [40] 0 0
Ballerup
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
Finland
State/province [42] 0 0
Kuopio
Country [43] 0 0
Finland
State/province [43] 0 0
Oulu
Country [44] 0 0
Finland
State/province [44] 0 0
Turku
Country [45] 0 0
France
State/province [45] 0 0
Corbeil Essonnes
Country [46] 0 0
France
State/province [46] 0 0
Dommartin Les Toul
Country [47] 0 0
France
State/province [47] 0 0
Montpellier
Country [48] 0 0
France
State/province [48] 0 0
Narbonne
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
France
State/province [50] 0 0
Salouel
Country [51] 0 0
Germany
State/province [51] 0 0
Aschaffenburg
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Damme
Country [54] 0 0
Germany
State/province [54] 0 0
Dresden
Country [55] 0 0
Germany
State/province [55] 0 0
Essen
Country [56] 0 0
Germany
State/province [56] 0 0
Falkensee
Country [57] 0 0
Germany
State/province [57] 0 0
Hamburg
Country [58] 0 0
Germany
State/province [58] 0 0
Ludwigshafen
Country [59] 0 0
Germany
State/province [59] 0 0
Mainz
Country [60] 0 0
Germany
State/province [60] 0 0
München
Country [61] 0 0
Germany
State/province [61] 0 0
Münster
Country [62] 0 0
Germany
State/province [62] 0 0
Neuwied
Country [63] 0 0
Germany
State/province [63] 0 0
Nürnberg
Country [64] 0 0
Germany
State/province [64] 0 0
Pirna
Country [65] 0 0
Germany
State/province [65] 0 0
Rhaunen
Country [66] 0 0
Germany
State/province [66] 0 0
Villingen-Schwenningen
Country [67] 0 0
Germany
State/province [67] 0 0
Zwenkau
Country [68] 0 0
Greece
State/province [68] 0 0
Thessaloniki
Country [69] 0 0
Guatemala
State/province [69] 0 0
Guatemala
Country [70] 0 0
Israel
State/province [70] 0 0
Beer Sheva
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Holon
Country [73] 0 0
Israel
State/province [73] 0 0
Jerusalem
Country [74] 0 0
Israel
State/province [74] 0 0
Kfar Saba
Country [75] 0 0
Israel
State/province [75] 0 0
Petach Tikva
Country [76] 0 0
Israel
State/province [76] 0 0
Ramat Gan
Country [77] 0 0
Israel
State/province [77] 0 0
Tel Aviv
Country [78] 0 0
Italy
State/province [78] 0 0
Friuli-Venezia Giulia
Country [79] 0 0
Italy
State/province [79] 0 0
Liguria
Country [80] 0 0
Italy
State/province [80] 0 0
Lombardia
Country [81] 0 0
Italy
State/province [81] 0 0
Sardegna
Country [82] 0 0
Italy
State/province [82] 0 0
Toscana
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Seoul
Country [84] 0 0
Mexico
State/province [84] 0 0
Acapulco
Country [85] 0 0
Mexico
State/province [85] 0 0
Aguascalientes
Country [86] 0 0
Mexico
State/province [86] 0 0
Chihuahua
Country [87] 0 0
Mexico
State/province [87] 0 0
Durango
Country [88] 0 0
Mexico
State/province [88] 0 0
Guadalajara
Country [89] 0 0
Mexico
State/province [89] 0 0
Monterrey
Country [90] 0 0
Mexico
State/province [90] 0 0
Tampico
Country [91] 0 0
New Zealand
State/province [91] 0 0
Auckland
Country [92] 0 0
Peru
State/province [92] 0 0
Arequipa
Country [93] 0 0
Peru
State/province [93] 0 0
Lima
Country [94] 0 0
Puerto Rico
State/province [94] 0 0
Ponce
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Barnaul
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moscow
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Nizhny Novgorod
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Novosibirsk
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Omsk
Country [100] 0 0
Russian Federation
State/province [100] 0 0
S. Petersburg
Country [101] 0 0
Russian Federation
State/province [101] 0 0
S.Petersburg
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Saint-Petersburg
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Saratov
Country [104] 0 0
Russian Federation
State/province [104] 0 0
St Petersburg
Country [105] 0 0
Russian Federation
State/province [105] 0 0
St-Petersburg
Country [106] 0 0
Russian Federation
State/province [106] 0 0
St. Petersburg
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Tomsk
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Yaroslavl
Country [109] 0 0
South Africa
State/province [109] 0 0
Cape Town
Country [110] 0 0
South Africa
State/province [110] 0 0
Pretoria
Country [111] 0 0
Spain
State/province [111] 0 0
Alicante
Country [112] 0 0
Spain
State/province [112] 0 0
Valencia
Country [113] 0 0
Spain
State/province [113] 0 0
Almeria
Country [114] 0 0
Spain
State/province [114] 0 0
Madrid
Country [115] 0 0
Sweden
State/province [115] 0 0
Karlstad
Country [116] 0 0
Sweden
State/province [116] 0 0
Stockholm
Country [117] 0 0
Sweden
State/province [117] 0 0
Uppsala
Country [118] 0 0
Sweden
State/province [118] 0 0
Örebro
Country [119] 0 0
Switzerland
State/province [119] 0 0
Zürich
Country [120] 0 0
Thailand
State/province [120] 0 0
Bangkok
Country [121] 0 0
Ukraine
State/province [121] 0 0
Dnipropetrovs'k
Country [122] 0 0
Ukraine
State/province [122] 0 0
Donetsk
Country [123] 0 0
Ukraine
State/province [123] 0 0
Kiev
Country [124] 0 0
Ukraine
State/province [124] 0 0
Lviv
Country [125] 0 0
Ukraine
State/province [125] 0 0
Odessa
Country [126] 0 0
Ukraine
State/province [126] 0 0
Simferopol
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Bath
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Bradford on Avon
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Glasgow
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Lanarkshire
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Trowbridge

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/ct2/show/NCT00717457
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/NCT00717457