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Trial information
A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Status: Recruiting
Protocol number: BC21713
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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.
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 1 year, and the target sample size is 500+ individuals. Target sample size is 630.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: taspoglutide
Primary outcome: 1. Mean changes in HbA1c Time frame: 24 weeks
Key secondary outcomes: 1. 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. Time frame: 24 weeks
2. Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. Time frame: Throughout study
Inclusion criteria: - 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.
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;
- 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: October, 2008
Trial registration date: 09/17/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:Argentina - Buenos Aires
- Mar Del Plata
Australia Brazil - Belem - Pa
- Brasilia
- Campinas - Sp
- Fortaleza
- Fortaleza - Ce
- Goiania - Go
- Mogi Das Cruzes - Sp
- Porto Alegre
- Recife
- Rio De Janeiro
- Sao Paulo
- Sao Paulo - Sp
Bulgaria - Dimitrovgrad
- Pleven
- Plovdiv
- Ruse
- Sofia
Canada - London, ON
- Toronto, ON
- Montreal, QC
- Pointe-Claire, QC
Denmark France - Bondy
- Nantes
- Poitiers
- Rennes
- Saint-Mandé
Germany - Berlin
- Dormagen
- Dresden
- Görlitz
- Kiel Kronshagen
- München
- Sulzbach-Rosenberg
- Villingen-Schwenningen
Greece - Athens
- Larissa
- Nikea
- Thessaloniki
Korea, Republic of Mexico - Aguascalientes
- Cuernavaca
- Guadalajara
- Hermosillo
- Mexico City
- Monterrey
- Pachuca
- San Luis Potosi
Norway Peru Poland - Bialystok
- Gdansk
- Kamieniec Zabkowicki
- Rzeszow
- Skierniewice
- Sobótka
- Warszawa
- Wroclaw
Romania - Bucuresti
- Buzau
- Cluj-Napoca
- Ploiesti
Slovakia - Levice
- Presov
- Samorin
- Trebisov
- Trencin
South Africa Spain - Almeria
- Bacarot Alicant
- Sevilla
- Valencia
Sweden Switzerland Taiwan - Taichung
- Taipei
- Taoyuan Hsien
Thailand Turkey United Kingdom - Bexhill On Sea
- Crawley
- Glasgow
- Hinckley
- Reading
United States - Birmingham, AL
- Huntsville, AL
- Tallassee, AL
- Phoenix, AZ
- Little Rock, AR
- Huntington Beach, CA
- La Jolla, CA
- Los Angeles, CA
- Roseville, CA
- San Francisco, CA
- Colorado Springs, CO
- New London, CT
- Daytona Beach, FL
- Hialeah, FL
- Jacksonville, FL
- Miami, FL
- Panama City, FL
- St Petersburg, FL
- Augusta, GA
- Conyers, GA
- Snellville, GA
- Honolulu, HI
- Indianapolis , IN
- Lafayette, IN
- South Bend, IN
- Baltimore, MD
- Brockton, MA
- Cadillac, MI
- Brooklyn Center, MN
- St. Peters, MO
- Fulton, NY
- Hudson, NY
- Rochester, NY
- Charlotte, NC
- Raleigh, NC
- Shelby, NC
- Statesville, NC
- Winston-Salem, NC
- Columbus, OH
- Delaware, OH
- Marion, OH
- Corvallis, OR
- Eugene, OR
- Aliquippa, PA
- Beaver, PA
- Erie, PA
- Lancaster, PA
- Reading, PA
- Shippensburg, PA
- Warminster, PA
- Caguas, PR
- Carolina, PR
- Manati, PR
- Anderson, SC
- Kingsport, TN
- Dallas, TX
- Houston, TX
- South Burlington, VT
- Hampton, VA
- Norfolk , VA
- Richmond, VA
- Federal Way, WA
- Tacoma, WA
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