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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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- Freemantle
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2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
6959 - Freemantle
Recruitment outside Australia
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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/study/NCT00755287
Trial related presentations / publications
Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.
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/study/NCT00755287