A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.
2 other identifiers
interventional
666
23 countries
148
Brief Summary
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and 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 2+ years, and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Oct 2008
Typical duration for phase_3 diabetes-mellitus-type-2
148 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
First Submitted
Initial submission to the registry
September 17, 2008
CompletedFirst Posted
Study publicly available on registry
September 18, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedNovember 4, 2016
November 1, 2016
2.4 years
September 17, 2008
November 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean changes in HbA1c
24 weeks
Secondary Outcomes (2)
Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; change from baseline in lipid profile; beta cell function.
24 weeks
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Throughout study
Study Arms (4)
Placebo
PLACEBO COMPARATOROnce daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Sitagliptin
ACTIVE COMPARATOROnce daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Taspoglutide 10 mg
EXPERIMENTALOnce weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Taspoglutide up-titrated to 20 mg
EXPERIMENTALOnce weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Interventions
Once daily oral administration of placebo (matching sitagliptin).
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin (\>=1500mg/day) for at least 12 weeks;
- 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.
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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
Unknown Facility
Birmingham, Alabama, 35233, United States
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Huntsville, Alabama, 35802, United States
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Tallassee, Alabama, 36078, United States
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Scottsdale, Arizona, 85254, United States
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Little Rock, Arkansas, 72205, United States
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Huntington Beach, California, 92646, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90017, United States
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Roseville, California, 95661, United States
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San Francisco, California, 94109, United States
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Tacoma, California, 98405, United States
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Colorado Springs, Colorado, 80904, United States
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New London, Connecticut, 06320, United States
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Manati, District of Columbia, 00674, United States
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Daytona Beach, Florida, 32117, United States
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Hialeah, Florida, 33012, United States
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Jacksonville, Florida, 32205, United States
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Miami, Florida, 33186, United States
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Panama City, Florida, 32401, United States
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Tampa, Florida, 33606, United States
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Augusta, Georgia, 30904, United States
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Conyers, Georgia, 30094, United States
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Snellville, Georgia, 30029, United States
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Honolulu, Hawaii, 96813, United States
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Indianapolis, Indiana, 46229, United States
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Indianapolis, Indiana, 46254, United States
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Lafayette, Indiana, 47905, United States
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South Bend, Indiana, 46628, United States
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Baltimore, Maryland, 21229, United States
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Brockton, Massachusetts, 02301, United States
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Cadillac, Michigan, 49601, United States
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Brooklyn Center, Minnesota, 55430, United States
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Minneapolis, Minnesota, 55416, United States
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City of Saint Peters, Missouri, 63376, United States
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Fulton, New York, 13069, United States
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Hudson, New York, 12534, United States
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Rochester, New York, 14609, United States
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Charlotte, North Carolina, 28211, United States
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Raleigh, North Carolina, 27609, United States
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Shelby, North Carolina, 28150, United States
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Statesville, North Carolina, 28625, United States
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Winston-Salem, North Carolina, 27103, United States
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Columbus, Ohio, 43213, United States
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Delaware, Ohio, 43015, United States
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Marion, Ohio, 43302, United States
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Corvallis, Oregon, 97330, United States
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Eugene, Oregon, 97401, United States
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Aliquippa, Pennsylvania, 15001, United States
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Beaver, Pennsylvania, 15009, United States
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Erie, Pennsylvania, 16508, United States
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Reading, Pennsylvania, 17601, United States
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Reading, Pennsylvania, 19606, United States
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Shippensburg, Pennsylvania, 17257, United States
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Warminster, Pennsylvania, 18974, United States
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Anderson, South Carolina, 29621, United States
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Kingsport, Tennessee, 37660, United States
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Dallas, Texas, 75230, United States
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Houston, Texas, 77030, United States
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South Burlington, Vermont, 05403, United States
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Hampton, Virginia, 23666, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23249, United States
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Richmond, Virginia, 23294, United States
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Federal Way, Washington, 98003, United States
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Buenos Aires, C1012, Argentina
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Buenos Aires, C1213AAH, Argentina
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Mar del Plata, B7600DHK, Argentina
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Freemantle, Queensland, 6959, Australia
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Adelaide, South Australia, 5000, Australia
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London, Ontario, N6A 4V2, Canada
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Thornhill, Ontario, L4J 8L7, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Bondy, 93143, France
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Nantes, 44093, France
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Poitiers, 86021, France
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Rennes, 35203, France
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Saint-Mandé, 94163, France
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Berlin, 10115, Germany
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Dormagen, 41539, Germany
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Dresden, 01307, Germany
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Kiel Kronshagen, 24119, Germany
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München, 80336, Germany
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Sulzbach-Rosenberg, 92237, Germany
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Villingen-Schwenningen, 78048, Germany
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Larissa, 41110, Greece
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Cuernavaca, 62250, Mexico
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Hermosillo, 83200, Mexico
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Jalisco, 44690, Mexico
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Mexico City, 06700, Mexico
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Mexico City, 11520, Mexico
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Monterrey, 64000, Mexico
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Pachuca, 42086, Mexico
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Elverum, 2401, Norway
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Oslo, 0027, Norway
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Oslo, 0176, Norway
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Oslo, 0407, Norway
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Lima, Lima 33, Peru
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Lima, Lima 9, Peru
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Bialystok, 15-445, Poland
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Gdansk, 80-858, Poland
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Kamieniec Ząbkowicki, 57-230, Poland
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Rzeszów, 35-073, Poland
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Skierniewice, 96-100, Poland
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Sobótka, 55-050, Poland
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Wroclaw, 51-124, Poland
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Caguas, 00725, Puerto Rico
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Carolina, 00983, Puerto Rico
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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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Levice, 93405, Slovakia
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Prešov, 080 01, Slovakia
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Šamorín, 931 01, Slovakia
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Trebišov, 07501, Slovakia
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Trenčín, 911 01, Slovakia
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Cape Town, 7130, South Africa
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Pretoria, 0002, South Africa
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Gyeonggi-do, 443-380, South Korea
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Gyeonggi-do, South Korea
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Seoul, 152-703, South Korea
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Seoul, South Korea
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Wŏnju, 220-701, South Korea
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Bacarot Alicant, Alicante, 03114, Spain
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Almería, Almeria, 04001, Spain
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Seville, Sevilla, 41010, Spain
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Valencia, Valencia, 46014, Spain
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Ljungby, 34182, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 14186, Sweden
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Basel, 4031, Switzerland
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Geneva, 1211, Switzerland
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Zurich, 8063, Switzerland
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Taichung, 407, Taiwan
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Taipei, 114, Taiwan
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Taipei, 220, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Songkhla, 90112, Thailand
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Istanbul, 34390, Turkey (Türkiye)
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Bexhill-on-Sea, TN39 4SP, United Kingdom
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Crawley, RH10 7DX, United Kingdom
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Glasgow, G46 8NY, United Kingdom
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Hinckley, LE10 2SE, United Kingdom
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Reading, RG7 3SQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
September 17, 2008
First Posted
September 18, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
November 4, 2016
Record last verified: 2016-11