A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
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
2 other identifiers
interventional
373
11 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Aug 2008
Typical duration for phase_3 diabetes-mellitus-type-2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 28, 2016
July 1, 2016
1.7 years
August 29, 2008
July 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline in HbA1c
24 weeks
Secondary Outcomes (3)
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Throughout study
Change from baseline in fasting plasma glucose; change from baseline in body weight.
24 weeks
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.
24 weeks
Study Arms (3)
placebo
PLACEBO COMPARATORtaspoglutide 10mg sc
EXPERIMENTALtaspoglutide 10mg/20mg sc
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Unknown Facility
Phoenix, Arizona, 85015, United States
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Los Angeles, California, 90057, United States
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Santa Ana, California, 92701, United States
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Avon, Indiana, 46123, United States
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Pahrump, Nevada, 89048, United States
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Charlotte, North Carolina, 28211, United States
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Greer, South Carolina, 29651, United States
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Mt. Pleasant, South Carolina, 29464, United States
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San Antonio, Texas, 78237, United States
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Richmond, Virginia, 23294, United States
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Adelaide, 5000, Australia
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St Leonards, 2065, Australia
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Guatemala City, 01010, Guatemala
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Guatemala City, 01014, Guatemala
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Haifa, 31096, Israel
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Haifa, 34162, Israel
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Holon, 58100, Israel
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Jerusalem, 91200, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 64239, Israel
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Acapulco, 39670, Mexico
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Aguascalientes, 20230, Mexico
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Chihuahua City, 31238, Mexico
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Hermosillo, 83200, Mexico
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Mexico City, 11650, Mexico
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Morelia, 58000, Mexico
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Lima, Lima 33, Peru
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San Isidro, 27, Peru
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Bucharest, 020359, Romania
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Buzău, 120203, Romania
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Cluj-Napoca, 400006, Romania
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Ploieşti, 100163, Romania
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Ploieşti, 100342, Romania
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Tg. Mures, 540142, Romania
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Chelyabinsk, 454136, Russia
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Jaloslave, Russia
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Moscow, 109263, Russia
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Moscow, 117036, Russia
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Moscow, 119048, Russia
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Moscow, 129110, Russia
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S. Petersburg, 195067, Russia
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S.petersburg, 194017, Russia
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Saint Petersburg, 191124, Russia
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Yaroslavl, 150062, Russia
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Dolný Kubín, 02601, Slovakia
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Levice, 034 01, Slovakia
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Prešov, 080 01, Slovakia
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Trenčín, 911 01, Slovakia
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Žilina, 010 01, Slovakia
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Changhua, 500, Taiwan
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Tainan, 710, Taiwan
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Taipei, 100, Taiwan
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Tapei County, 231, Taiwan
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Chernivtsi, 58002, Ukraine
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Kiev, 01601, Ukraine
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Kiev, 04050, Ukraine
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Lviv, 79010, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2008
First Posted
September 1, 2008
Study Start
August 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 28, 2016
Record last verified: 2016-07