Trial information
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Status: Recruiting
Protocol number: BC20750
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
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. Target sample size is 330.
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. 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. Time frame: 24 weeks
2. 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. 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, 18-80 years of age;
- drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
- tested negative for 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.
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;
- 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: 80 Years
Accepts healthy volunteers: No
Anticipated start date: August, 2008
Trial registration date: 08/29/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
Brazil
- Belem - Pa
- Brasilia
- Campina Grande Do Sul
- Campinas
- Campinas - Sp
- Fortaleza
- Fortaleza - Ce
- Goiania - Go
- Maringa - Pr
- Mogi Das Cruzes - Sp
- Porto Alegre
- Recife
- Rio De Janeiro
- Sao Paulo
- Sao Paulo - Sp
- São Paulo - Sp
Bulgaria
- Dimitrovgrad
- Pleven
- Plovdiv
- Sofia
Guatemala
Israel
- Haifa
- Holon
- Jerusalem
- Kfar Saba
- Petach Tikva
- Tel Aviv
Mexico
- Acapulco
- Aguascalientes
- Chihuahua
- Hermosillo
- Mexico City
- Morelia
Peru
Romania
- Bucuresti
- Buzau
- Cluj-Napoca
- Ploiesti
- Tg. Mures
Russian Federation
- Chelyabinsk
- Jaloslave
- Moscow
- S. Petersburg
- S. Petersburg
- St.Petersburg
- Yaroslavl
Serbia and Montenegro
Slovakia
- Dolny Kubin
- Levice
- Presov
- Trencin
- Zilina
Taiwan
- Changhua
- Tainan
- Taipei
- Tapei County
Ukraine
- Chernovtsy
- Kiev
- Lvov
- Odessa
United States
- Phoenix, AZ
- Los Angeles, CA
- Santa Ana, CA
- Avon, IN
- Pahrump, NV
- Charlotte, NC
- Greer, SC
- Mount Pleasant, SC
- San Antonio, TX
- Richmond, VA
