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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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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
This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared
to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and
exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once
weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide
10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once
weekly). The anticipated time on study treatment is 1 year, and the target sample size is
100-500 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00744926
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/NCT00744926