|
|
 |
|
 |
|
Trial information
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Status: Recruiting
Protocol number: BC20965
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A multicenter, randomized, open-label, active-controlled study to compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve type 2 diabetic patients inadequately controlled with metformin and sulphonylurea combination therapy
Brief summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 1 year, and the target sample size if 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. Absolute change from baseline 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%); incidence of hypoglycemia; change from baseline in lipid profile. Time frame: 24 weeks
2. Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. Time frame: 24 weeks
3. 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 treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
- C-peptide (fasting) >=1.0ng/mL;
- 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;
- symptomatic poorly controlled diabetes;
- 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: November, 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:Australia - Freemantle
- St. Leonards
- Wollongong
Austria Belgium - Arlon
- Bonheiden
- Leuven
- Liege
Brazil - Campina Grande Do Sul
- Campinas
- Curitiba
- Fortaleza - Ce
- Porto Alegre
- Recife
- Santos
- Sao Paulo
- Sao Paulo - Sp
Canada - Vancouver, BC
- Sherbrooke, NS
- Hamilton, ON
- London, ON
- Toronto, ON
- Pointe-Claire, QC
China Czech Republic - Brno
- Havirov-Sumbark
- Plzen
- Praha
- Trutnov
Finland - Helsinki
- Jyvaeskylae
- Tampere
France - Avignon
- Besancon
- Brest
- Corbeil-Essonnes
- La Rochelle
- Marseille
- Montpellier
- Nimes
- Paris
- Rouen
- Strasbourg
- Venissieux
Germany - Bad Lauterberg
- Berlin
- Bochum
- Bosenheim
- Dortmund
- Falkensee
- Freiburg I.Brsg.
- Mainz
- Offenbach A.M.
- Reichenbach
- Würzburg
Greece - Athens
- Larissa
- Thessaloniki
Guatemala Hungary - Balatonfuered
- Budapest
- Szekszard
Italy - Codogno
- Milano
- Napoli
- Padova
- Roma
- Torino
Mexico - Aguascalientes
- Chihuahua
- Cuernavaca
- Guadalajara
- Mexico City
- Monterrey
- Pachuca
- Tampico
New Zealand Peru - Arequipa
- Callao
- Lima
- Trujillo
Poland - Grodzisk Mazowiecki
- Kamieniec Zabkowicki
- Lodz
- Poznan
- Rzeszow
- Sobótka
- Szczecin
- Wroclaw
Portugal Russian Federation - Barnaul
- Chelyabinsk
- Moscow
- Nizhny Novgorod
- Novosibirsk
- Omsk
- St Petersburg
- St. Petersburg
- St-Petersburg
- Tomsk
Spain - Almeria
- Alzira
- Barcelona
- Granada
- Pozuelo De Alarcon
- Sevilla
- Valencia
- Valladolid
Thailand United Kingdom - Atherstone
- Chesterfield
- Dundee
- Liverpool
- Sheffield
United States - Muscle Shoals, AL
- Searcy, AR
- Concord, CA
- Huntington Beach, CA
- Los Angeles, CA
- Los Gatos, CA
- Roseville, CA
- San Diego , CA
- Santa Ana, CA
- Westlake Village, CA
- Washington, DC
- Gainesville, FL
- Hialeah, FL
- Jacksonville, FL
- New Port Richey , FL
- Ormond Beach, FL
- Oviedo, FL
- Palm Harbor, FL
- Zephyrhills, FL
- Atlanta, GA
- Honolulu, HI
- Champaign, IL
- Quincy, IL
- Springfield, IL
- Avon, IN
- Indianapolis , IN
- Arkansas City, KS
- Crestview Hills, KY
- Metairie, LA
- New Orleans, LA
- Sunset, LA
- Portland, ME
- North East, MD
- Worcester, MA
- St. Clair Shores, MI
- Jackson, MS
- Picayune, MS
- Marionville, MO
- Grand Island, NE
- Omaha, NE
- Henderson , NV
- Blackwood, NJ
- Cherry Hill, NJ
- Moorestown, NJ
- Toms River, NJ
- Albany, NY
- Flushing, NY
- Mineola, NY
- Asheville, NC
- Concord, NC
- Fargo, ND
- Centerville, OH
- Cincinnati, OH
- Genoa, OH
- Toledo, OH
- Altoona, PA
- Bensalem, PA
- Clairton, PA
- Feasterville, PA
- Harrisburg, PA
- Philadelphia, PA
- Scranton, PA
- Tipton, PA
- Guyanabo, San Juan, PR
- Levittown, PR
- Orocovis, PR
- Ponce, PR
- Trujillo Alto, PR
- Orangeburg, SC
- Johnson City, TN
- Dallas, TX
- Houston, TX
- Orange, VA
- Richmond, VA
- Tacoma, WA
- Menomonee Falls, WI
|
|
 |
|
