COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. 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/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
Gender
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
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,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/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
Other publications