Clinical trial NCT00823992: A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks;
* HbA1c \>=6.5% and \<=9.5% at screening;
* BMI \>=30 and \<=50 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

* history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
* evidence of clinically significant diabetic complications;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Primary outcomes:
measure: Absolute change from baseline in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in body weight;% of patients achieving >=5% weight loss
timeFrame: 24 weeks
measure: % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
timeFrame: 24 weeks
measure: Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n
timeFrame: At planned clinic visits, for 12 months
Other outcomes:
Locations:
city: Bermuda Dunes
country: United States
state: California
city: Lajolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Brooksville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Avon
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Royal Oak
country: United States
state: Michigan
city: Picayune
country: United States
state: Mississippi
city: Clifton
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Norman
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Clinton
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Vancouver
country: Canada
state: British Columbia
city: Sherbrooke
country: Canada
state: Nova Scotia
city: Etobicoke
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Falkensee
country: Germany
city: Mainz
country: Germany
city: Münster
country: Germany
city: Neuwied
country: Germany
city: Ancona
country: Italy
city: Ravenna
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Bitola
country: Macedonia, The Former Yugoslav Republic of
city: Gniewkowo
country: Poland
city: Kamieniec Zabkowicki
country: Poland
city: Lublin
country: Poland
city: Carolina
country: Puerto Rico
city: Rio Grande
country: Puerto Rico
city: Rio Piedras
country: Puerto Rico
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Tumen
country: Russian Federation
city: Barcelona
country: Spain
city: Lerida
country: Spain
city: Oviedo
country: Spain
city: Bath
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Midsomer Norton
country: United Kingdom
city: Rotherham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: