- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00744926
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
July 26, 2016 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
373
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia, 5000
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St. Leonards, Australia, 2065
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Guatemala, Guatemala, 01010
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Guatemala, Guatemala, 01014
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Haifa, Israel, 31096
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Haifa, Israel, 34162
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Holon, Israel, 58100
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Jerusalem, Israel, 91200
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Kfar Saba, Israel, 44281
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Petach Tikva, Israel, 49100
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Tel Aviv, Israel, 64239
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Acapulco, Mexico, 39670
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Aguascalientes, Mexico, 20230
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Chihuahua, Mexico, 31238
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Hermosillo, Mexico, 83200
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Mexico City, Mexico, 11650
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Morelia, Mexico, 58000
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Lima, Peru, Lima 33
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San Isidro, Peru, 27
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Bucuresti, Romania, 020359
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Buzau, Romania, 120203
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Cluj-napoca, Romania, 400006
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Ploiesti, Romania, 100163
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Ploiesti, Romania, 100342
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Tg. Mures, Romania, 540142
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Chelyabinsk, Russian Federation, 454136
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Jaloslave, Russian Federation
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Moscow, Russian Federation, 129110
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Moscow, Russian Federation, 117036
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Moscow, Russian Federation, 109263
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Moscow, Russian Federation, 119048
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S. Petersburg, Russian Federation, 195067
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S.petersburg, Russian Federation, 194017
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St. Petersburg, Russian Federation, 191124
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Yaroslavl, Russian Federation, 150062
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Dolny Kubin, Slovakia, 02601
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Levice, Slovakia, 034 01
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Presov, Slovakia, 080 01
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Trencin, Slovakia, 911 01
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Zilina, Slovakia, 010 01
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Changhua, Taiwan, 500
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Tainan, Taiwan, 710
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Taipei, Taiwan, 100
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Tapei County, Taiwan, 231
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Chernovtsy, Ukraine, 58002
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Kiev, Ukraine, 01601
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Kiev, Ukraine, 04050
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Lviv, Ukraine, 79010
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Arizona
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Phoenix, Arizona, United States, 85015
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California
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Los Angeles, California, United States, 90057
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Santa Ana, California, United States, 92701
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Indiana
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Avon, Indiana, United States, 46123
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Nevada
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Pahrump, Nevada, United States, 89048
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North Carolina
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Charlotte, North Carolina, United States, 28211
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South Carolina
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Greer, South Carolina, United States, 29651
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Mount Pleasant, South Carolina, United States, 29464
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Texas
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San Antonio, Texas, United States, 78237
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Virginia
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Richmond, Virginia, United States, 23294
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: placebo
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sc, once weekly
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Experimental: taspoglutide 10mg sc
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10mg sc, once weekly
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
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Experimental: taspoglutide 10mg/20mg sc
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10mg sc, once weekly
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Absolute change from baseline in HbA1c
Time Frame: 24 weeks
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Time Frame: Throughout study
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Throughout study
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Change from baseline in fasting plasma glucose; change from baseline in body weight.
Time Frame: 24 weeks
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24 weeks
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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.
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
August 29, 2008
First Submitted That Met QC Criteria
August 29, 2008
First Posted (Estimate)
September 1, 2008
Study Record Updates
Last Update Posted (Estimate)
July 28, 2016
Last Update Submitted That Met QC Criteria
July 26, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC20750
- 2008-001765-28
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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