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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00744926




Registration number
NCT00744926
Ethics application status
Date submitted
29/08/2008
Date registered
1/09/2008
Date last updated
28/07/2016

Titles & IDs
Public title
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Secondary ID [1] 0 0
2008-001765-28
Secondary ID [2] 0 0
BC20750
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 - placebo
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide

Placebo comparator: placebo -

Experimental: taspoglutide 10mg sc -

Experimental: taspoglutide 10mg/20mg sc -


Treatment: Drugs: placebo
sc, once weekly

Treatment: Drugs: taspoglutide
10mg sc, once weekly

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

Eligibility
Key inclusion criteria
* adult patients, 18-80 years of age;
* drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
* tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
* C-peptide (fasting) >=1.0ng/mL
* HbA1c >=6.5% 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
80 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;
* 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
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
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
373
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Guatemala
State/province [9] 0 0
Guatemala
Country [10] 0 0
Israel
State/province [10] 0 0
Haifa
Country [11] 0 0
Israel
State/province [11] 0 0
Holon
Country [12] 0 0
Israel
State/province [12] 0 0
Jerusalem
Country [13] 0 0
Israel
State/province [13] 0 0
Kfar Saba
Country [14] 0 0
Israel
State/province [14] 0 0
Petach Tikva
Country [15] 0 0
Israel
State/province [15] 0 0
Tel Aviv
Country [16] 0 0
Mexico
State/province [16] 0 0
Acapulco
Country [17] 0 0
Mexico
State/province [17] 0 0
Aguascalientes
Country [18] 0 0
Mexico
State/province [18] 0 0
Chihuahua
Country [19] 0 0
Mexico
State/province [19] 0 0
Hermosillo
Country [20] 0 0
Mexico
State/province [20] 0 0
Mexico City
Country [21] 0 0
Mexico
State/province [21] 0 0
Morelia
Country [22] 0 0
Peru
State/province [22] 0 0
Lima
Country [23] 0 0
Peru
State/province [23] 0 0
San Isidro
Country [24] 0 0
Romania
State/province [24] 0 0
Bucuresti
Country [25] 0 0
Romania
State/province [25] 0 0
Buzau
Country [26] 0 0
Romania
State/province [26] 0 0
Cluj-napoca
Country [27] 0 0
Romania
State/province [27] 0 0
Ploiesti
Country [28] 0 0
Romania
State/province [28] 0 0
Tg. Mures
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Chelyabinsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Jaloslave
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Moscow
Country [32] 0 0
Russian Federation
State/province [32] 0 0
S. Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
S.petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
St. Petersburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Yaroslavl
Country [36] 0 0
Slovakia
State/province [36] 0 0
Dolny Kubin
Country [37] 0 0
Slovakia
State/province [37] 0 0
Levice
Country [38] 0 0
Slovakia
State/province [38] 0 0
Presov
Country [39] 0 0
Slovakia
State/province [39] 0 0
Trencin
Country [40] 0 0
Slovakia
State/province [40] 0 0
Zilina
Country [41] 0 0
Taiwan
State/province [41] 0 0
Changhua
Country [42] 0 0
Taiwan
State/province [42] 0 0
Tainan
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
Taiwan
State/province [44] 0 0
Tapei County
Country [45] 0 0
Ukraine
State/province [45] 0 0
Chernovtsy
Country [46] 0 0
Ukraine
State/province [46] 0 0
Kiev
Country [47] 0 0
Ukraine
State/province [47] 0 0
Lviv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00744926