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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00754988




Registration number
NCT00754988
Ethics application status
Date submitted
17/09/2008
Date registered
18/09/2008
Date last updated
4/11/2016

Titles & IDs
Public title
A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Scientific title
A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.
Secondary ID [1] 0 0
2008-001854-42
Secondary ID [2] 0 0
BC21713
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 - Metformin
Treatment: Drugs - Placebo (matching sitagliptin)
Treatment: Drugs - Placebo (matching taspoglutide)
Treatment: Drugs - Sitagliptin
Treatment: Drugs - Taspoglutide

Placebo Comparator: Placebo - Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.

Active Comparator: Sitagliptin - Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.

Experimental: Taspoglutide 10 mg - Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.

Experimental: Taspoglutide up-titrated to 20 mg - Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.


Treatment: Drugs: Metformin
As prescribed

Treatment: Drugs: Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).

Treatment: Drugs: Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).

Treatment: Drugs: Sitagliptin
Once daily oral administration of 100 mg of sitagliptin.

Treatment: Drugs: Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean changes 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%); responder rates for body weight; change from baseline in lipid profile; beta cell function.
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Timepoint [2] 0 0
Throughout study

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

- type 2 diabetes receiving metformin (>=1500mg/day) for at least 12 weeks;

- 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;

- 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
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
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)
QLD,SA
Recruitment hospital [1] 0 0
- Freemantle
Recruitment hospital [2] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
6959 - Freemantle
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
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Reading

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

Ethics approval
Ethics application status

Summary
Brief summary
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared
to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled
with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg
once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or
placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment.
After 24 weeks of treatment, patients on active treatment will continue on the same treatment
and 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 2+ years, and the target sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/show/NCT00754988
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