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Trial information
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
Status: Recruiting
Protocol number: BC21625
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Randomized, active controlled, open label study to compare Taspoglutide vs Exenatide as add-on treatment to metformin and/or thiazolidinediones in patients with type 2 diabetes mellitus
Brief summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals. Target sample size is 990.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: taspoglutide
Primary outcome: 1. Change in HbA1c Time frame: 24 weeks
Key secondary outcomes: 1. Fasting body weight Time frame: 24 weeks
2. Proportion of patients reaching target HbA1c <=7.0%, <=6.5% Time frame: 24 weeks
3. Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. Time frame: 24 weeks
4. Beta cell function (proinsulin/insulin ratio) Time frame: 24 weeks
Inclusion criteria: - adult patients, 18-75 years of age;
- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
- HbA1c >=7.0% and <=10% at screening;
- BMI >=25kg/m2 (>23kg/m2 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, diabetes resulting from pancreatic injury or secondary forms of diabetes;
- history of acute metabolic diabetic complications within the previous 6 months;
- evidence of clinically significant diabetic complications;
- known proliferative diabetic retinopathy;
- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
- any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
- known hemoglobinopathy or chronic anemia;
- clinically significant gastrointestinal disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2008
Trial registration date: 07/15/2008
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:Argentina Australia Brazil - Belem - Pa
- Brasilia
- Campinas - Sp
- Curitiba
- Fortaleza
- Fortaleza - Ce
- Goiania - Go
- Maringa - Pr
- Mogi Das Cruzes - Sp
- Porto Alegre
- Santos
- Sao Paulo
- Sao Paulo - Sp
Canada - London, ON
- Toronto, ON
- Pointe-Claire, QC
Denmark Finland - Helsinki
- Kuopio
- Oulu
- Turku
France - Corbeil-Essonnes
- Montpellier
- Narbonne
- Paris
Germany - Aschaffenburg
- Berlin
- Damme
- Dresden
- Essen
- Falkensee
- Hamburg
- Ludwigshafen
- Mainz
- München
- Münster
- Neuwied
- Nürnberg
- Pirna
- Rhaunen
- Villingen-Schwenningen
- Zwenkau
Greece Guatemala Israel - Beer Sheva
- Haifa
- Holon
- Jerusalem
- Kfar Saba
- Petach Tikva
- Ramat Gan
- Tel Aviv
Italy - Genova
- Olbia
- Pavia
- Pordenone
- Siena
Mexico - Acapulco
- Aguascalientes
- Chihuahua
- Durango
- Guadalajara
- Mexico City
- Monterrey
- Tampico
New Zealand Peru Russian Federation - Barnaul
- Moscow
- Nizhny Novgorod
- Novosibirsk
- Omsk
- S. Petersburg
- S. Petersburg
- Saratov
- St Petersburg
- St. Petersburg
- St.Petersburg
- St-Petersburg
- Tomsk
- Yaroslavl
South Africa Spain - Almeria
- Alzira
- Bacarot Alicant
- Madrid
Sweden - Karlstad
- Örebro
- Stockholm
- Uppsala
Switzerland Thailand Ukraine - Dnipropetrovs'K
- Donetsk
- Kiev
- Lvov
- Odessa
United Kingdom - Bath
- Bradford On Avon
- Glasgow
- Lanarkshire
- Trowbridge
United States - Haleyville, AL
- Mobile, AL
- Montgomery, AL
- Phoenix, AZ
- Little Rock, AR
- Duarte, CA
- Escondido, CA
- La Jolla, CA
- Mission Viejo, CA
- Orange, CA
- Palm Springs, CA
- Rancho Cucamonga, CA
- Sacramento, CA
- San Leandro, CA
- Daytona Beach, FL
- Green Cove Springs, FL
- Hialeah, FL
- Jacksonville, FL
- Miami, FL
- Orlando, FL
- Saint Cloud, FL
- Atlanta, GA
- Suwanee, GA
- Chicago, IL
- Peoria, IL
- Evansville, IN
- New Albany, IN
- Iowa City, IA
- Munfordville, KY
- Metairie, LA
- Bangor, ME
- Baltimore, MD
- Bethesda, MD
- Rockville, MD
- Detroit, MI
- Royal Oak, MI
- Jefferson City, MO
- Kansas City, MO
- Saint Louis, MO
- St Louis, MO
- Washington, MO
- Las Vegas, NV
- Concord, NH
- Trenton, NJ
- Voorhees, NJ
- Whitehouse, NJ
- Brooklyn, NY
- Mineola, NY
- New York, NY
- Rochester, NY
- Smithtown, NY
- Springfield Gardens, NY
- Staten Island, NY
- Syracuse, NY
- West Seneca, NY
- Westfield, NY
- Charlotte, NC
- Durham, NC
- Greensboro, NC
- Hickory , NC
- Hunters Ville, NC
- Salisbury, NC
- Winston-Salem, NC
- Fargo, ND
- Cincinnati, OH
- Cleveland, OH
- Columbus, OH
- Westlake, OH
- Medford, OR
- Altoona, PA
- Norristown, PA
- Philadelphia, PA
- Red Lion, PA
- Ponce, PR
- Providence, RI
- Clemson, SC
- Irmo, SC
- Simpsonville, SC
- Bristol, TN
- Austin, TX
- Houston, TX
- Richmond, VA
- Everett, WA
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