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/NCT00755287




Registration number
NCT00755287
Ethics application status
Date submitted
17/09/2008
Date registered
18/09/2008
Date last updated
29/07/2016

Titles & IDs
Public title
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Scientific title
A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy
Secondary ID [1] 0 0
2008-001855-23
Secondary ID [2] 0 0
BC20965
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 - insulin glargine
Treatment: Drugs - metformin
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide

Active Comparator: insulin glargine - insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment

Experimental: taspoglutide 10 mg - taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment

Experimental: taspoglutide 10 mg/20 mg - taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment


Treatment: Drugs: insulin glargine
starting dose 10 IU daily

Treatment: Drugs: metformin
As prescribed

Treatment: Drugs: taspoglutide
10 mg once weekly

Treatment: Drugs: taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg 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
Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile.
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies
Timepoint [3] 0 0
Throughout study

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

- type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least
12 weeks;

- C-peptide (fasting) >=1.0ng/mL;

- HbA1c >=7.0% and <=10.0% at screening;

- BMI >=25 (>23 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 mellitus or acute metabolic diabetic complications such as
ketoacidosis or hyperosmolar coma in the previous 6 months;

- evidence of clinically significant diabetic complications;

- symptomatic poorly controlled diabetes;

- clinically symptomatic gastrointestinal disease;

- myocardial infarction, coronary artery bypass surgery, post-transplantation
cardiomyopathy or stroke within the previous 6 months;

- known hemoglobinopathy or chronic anemia.

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
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
1072
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Wollongong
Recruitment hospital [3] 0 0
- Freemantle
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
6959 - Freemantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
District of Columbia
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
Kansas
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
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
North Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
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
Wisconsin
Country [31] 0 0
Austria
State/province [31] 0 0
Graz
Country [32] 0 0
Austria
State/province [32] 0 0
Salzburg
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Belgium
State/province [34] 0 0
Arlon
Country [35] 0 0
Belgium
State/province [35] 0 0
Bonheiden
Country [36] 0 0
Belgium
State/province [36] 0 0
Leuven
Country [37] 0 0
Belgium
State/province [37] 0 0
Liège
Country [38] 0 0
Brazil
State/province [38] 0 0
PE
Country [39] 0 0
Brazil
State/province [39] 0 0
PR
Country [40] 0 0
Brazil
State/province [40] 0 0
RS
Country [41] 0 0
Brazil
State/province [41] 0 0
SP
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Brno
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Havirov
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Plzen
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Praha
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Trutnov
Country [50] 0 0
Finland
State/province [50] 0 0
Helsinki
Country [51] 0 0
Finland
State/province [51] 0 0
Jyvaeskylae
Country [52] 0 0
Finland
State/province [52] 0 0
Tampere
Country [53] 0 0
France
State/province [53] 0 0
Avignon
Country [54] 0 0
France
State/province [54] 0 0
Besancon
Country [55] 0 0
France
State/province [55] 0 0
Bois Guillaume
Country [56] 0 0
France
State/province [56] 0 0
Brest
Country [57] 0 0
France
State/province [57] 0 0
Corbeil Essonnes
Country [58] 0 0
France
State/province [58] 0 0
La Rochelle
Country [59] 0 0
France
State/province [59] 0 0
Marseille
Country [60] 0 0
France
State/province [60] 0 0
Montpellier
Country [61] 0 0
France
State/province [61] 0 0
Nimes
Country [62] 0 0
France
State/province [62] 0 0
Paris
Country [63] 0 0
France
State/province [63] 0 0
Strasbourg
Country [64] 0 0
France
State/province [64] 0 0
Venissieux
Country [65] 0 0
Germany
State/province [65] 0 0
Bad Lauterberg
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
Country [67] 0 0
Germany
State/province [67] 0 0
Bochum
Country [68] 0 0
Germany
State/province [68] 0 0
Bosenheim
Country [69] 0 0
Germany
State/province [69] 0 0
Dortmund
Country [70] 0 0
Germany
State/province [70] 0 0
Falkensee
Country [71] 0 0
Germany
State/province [71] 0 0
Freiburg
Country [72] 0 0
Germany
State/province [72] 0 0
Mainz
Country [73] 0 0
Germany
State/province [73] 0 0
Offenbach a.M.
Country [74] 0 0
Germany
State/province [74] 0 0
Reichenbach
Country [75] 0 0
Germany
State/province [75] 0 0
Würzburg
Country [76] 0 0
Greece
State/province [76] 0 0
Athens
Country [77] 0 0
Greece
State/province [77] 0 0
Larissa
Country [78] 0 0
Greece
State/province [78] 0 0
Thessaloniki
Country [79] 0 0
Guatemala
State/province [79] 0 0
Guatemala
Country [80] 0 0
Hong Kong
State/province [80] 0 0
Hong Kong
Country [81] 0 0
Hungary
State/province [81] 0 0
Balatonfuered
Country [82] 0 0
Hungary
State/province [82] 0 0
Budapest
Country [83] 0 0
Hungary
State/province [83] 0 0
Szekszard
Country [84] 0 0
Italy
State/province [84] 0 0
Campania
Country [85] 0 0
Italy
State/province [85] 0 0
Lazio
Country [86] 0 0
Italy
State/province [86] 0 0
Lombardia
Country [87] 0 0
Italy
State/province [87] 0 0
Piemonte
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Daegu
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Incheon
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Seoul
Country [91] 0 0
Mexico
State/province [91] 0 0
Aguascalientes
Country [92] 0 0
Mexico
State/province [92] 0 0
Cuernavaca
Country [93] 0 0
Mexico
State/province [93] 0 0
Monterrey
Country [94] 0 0
Mexico
State/province [94] 0 0
Tampico
Country [95] 0 0
New Zealand
State/province [95] 0 0
Auckland
Country [96] 0 0
Peru
State/province [96] 0 0
Arequipa
Country [97] 0 0
Peru
State/province [97] 0 0
Lima
Country [98] 0 0
Peru
State/province [98] 0 0
Trujillo
Country [99] 0 0
Poland
State/province [99] 0 0
Grodzisk Mazowiecki
Country [100] 0 0
Poland
State/province [100] 0 0
Kamieniec Zabkowicki
Country [101] 0 0
Poland
State/province [101] 0 0
Lodz
Country [102] 0 0
Poland
State/province [102] 0 0
Rzeszow
Country [103] 0 0
Poland
State/province [103] 0 0
Sobótka
Country [104] 0 0
Poland
State/province [104] 0 0
Szczecin
Country [105] 0 0
Poland
State/province [105] 0 0
Wroclaw
Country [106] 0 0
Portugal
State/province [106] 0 0
Coimbra
Country [107] 0 0
Portugal
State/province [107] 0 0
Lisboa
Country [108] 0 0
Puerto Rico
State/province [108] 0 0
Guyanabo, San Juan
Country [109] 0 0
Puerto Rico
State/province [109] 0 0
Levittown
Country [110] 0 0
Puerto Rico
State/province [110] 0 0
Orocovis
Country [111] 0 0
Puerto Rico
State/province [111] 0 0
Ponce
Country [112] 0 0
Puerto Rico
State/province [112] 0 0
San Juan
Country [113] 0 0
Puerto Rico
State/province [113] 0 0
Trujillo Alto
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Barnaul
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Chelyabinsk
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Moscow
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Nizhny Novgorod
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Novosibirsk
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Omsk
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Saint-Petersburg
Country [121] 0 0
Russian Federation
State/province [121] 0 0
St Petersburg
Country [122] 0 0
Russian Federation
State/province [122] 0 0
St-Petersburg
Country [123] 0 0
Russian Federation
State/province [123] 0 0
St. Petersburg
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Tomsk
Country [125] 0 0
Serbia
State/province [125] 0 0
Belgrade
Country [126] 0 0
Serbia
State/province [126] 0 0
Kragujevac
Country [127] 0 0
Serbia
State/province [127] 0 0
Nis
Country [128] 0 0
Serbia
State/province [128] 0 0
Novi Sad
Country [129] 0 0
Spain
State/province [129] 0 0
Madrid
Country [130] 0 0
Spain
State/province [130] 0 0
Valencia
Country [131] 0 0
Spain
State/province [131] 0 0
Almeria
Country [132] 0 0
Spain
State/province [132] 0 0
Barcelona
Country [133] 0 0
Spain
State/province [133] 0 0
Granada
Country [134] 0 0
Spain
State/province [134] 0 0
Sevilla
Country [135] 0 0
Spain
State/province [135] 0 0
Valladolid
Country [136] 0 0
Thailand
State/province [136] 0 0
Bangkok
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Atherstone
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Chesterfield
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Dumfries
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Liverpool
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Sheffield
Country [142] 0 0
United Kingdom
State/province [142] 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
to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately
controlled with metformin and sulphonylurea combination therapy. Patients will be randomized
to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg
once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to
continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years,
and the target sample size if 500+ individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00755287
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/NCT00755287