Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/study/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/study/NCT00717457
Trial related presentations / publications
Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.
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/study/NCT00717457