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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.
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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
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Secondary ID [1]
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0
2008-001855-23
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Secondary ID [2]
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BC20965
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2
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Condition category
Condition code
Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute change from baseline in HbA1c
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Assessment method [1]
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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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.
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Assessment method [1]
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0
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.
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Assessment method [2]
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0
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies
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Assessment method [3]
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Timepoint [3]
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Throughout study
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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.
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
1072
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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- St. Leonards
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- Wollongong
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- Freemantle
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2065 - St. Leonards
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2500 - Wollongong
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Recruitment postcode(s) [3]
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6959 - Freemantle
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Chesterfield
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Country [139]
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United Kingdom
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Dumfries
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Country [140]
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United Kingdom
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State/province [140]
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Liverpool
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Country [141]
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United Kingdom
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State/province [141]
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Sheffield
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United Kingdom
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State/province [142]
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Trowbridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00755287
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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.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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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/NCT00755287
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