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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.
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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
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Secondary ID [1]
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2008-001765-28
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Secondary ID [2]
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BC20750
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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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Diabetes
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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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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Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
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Assessment method [1]
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Timepoint [1]
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Throughout study
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Secondary outcome [2]
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Change from baseline in fasting plasma glucose; change from baseline in body weight.
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Assessment method [2]
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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24 weeks
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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.
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Minimum age
18
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Maximum age
80
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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;
* 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
1/08/2008
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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
1/04/2010
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Sample size
Target
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Accrual to date
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Final
373
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- St. Leonards
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2065 - St. Leonards
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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Indiana
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Nevada
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North Carolina
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South Carolina
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Texas
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Virginia
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Guatemala
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Guatemala
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Mexico
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Acapulco
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Mexico
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Mexico
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Chihuahua
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Mexico
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Hermosillo
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Mexico
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Mexico City
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Mexico
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Morelia
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Peru
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Lima
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Peru
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Romania
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Bucuresti
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Romania
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Cluj-napoca
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Romania
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Ploiesti
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Romania
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Tg. Mures
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Russian Federation
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Chelyabinsk
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Russian Federation
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Jaloslave
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Moscow
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S. Petersburg
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S.petersburg
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St. Petersburg
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Russian Federation
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Yaroslavl
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Slovakia
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Dolny Kubin
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Slovakia
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Levice
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Presov
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Zilina
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Changhua
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Taiwan
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Tainan
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Taipei
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Taiwan
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Tapei County
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Ukraine
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Chernovtsy
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Kiev
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Ukraine
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Lviv
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00744926
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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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/NCT00744926
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