Clinical trial NCT00754988: A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 666
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 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 2+ years, and the target sample size is 500+ individuals.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean changes in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 weeks
measure: Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tallassee
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Huntington Beach
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Tacoma
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Manati
country: United States
state: District of Columbia
city: Daytona Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Cadillac
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: St. Peters
country: United States
state: Missouri
city: Fulton
country: United States
state: New York
city: Hudson
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Delaware
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Corvallis
country: United States
state: Oregon
city: Eugene
country: United States
state: Oregon
city: Aliquippa
country: United States
state: Pennsylvania
city: Beaver
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Shippensburg
country: United States
state: Pennsylvania
city: Warminster
country: United States
state: Pennsylvania
city: Anderson
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: South Burlington
country: United States
state: Vermont
city: Hampton
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Federal Way
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Mar del Plata
country: Argentina
city: Freemantle
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: London
country: Canada
state: Ontario
city: Thornhill
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Bondy
country: France
city: Nantes
country: France
city: Poitiers
country: France
city: Rennes
country: France
city: St Mande
country: France
city: Berlin
country: Germany
city: Dormagen
country: Germany
city: Dresden
country: Germany
city: Kiel Kronshagen
country: Germany
city: Muenchen
country: Germany
city: Sulzbach-Rosenberg
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Larissa
country: Greece
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Cuernavaca
country: Mexico
city: Hermosillo
country: Mexico
city: Jalisco
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Elverum
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Lima
country: Peru
city: Lima
country: Peru
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Kamieniec Zabkowicki
country: Poland
city: Rzeszow
country: Poland
city: Skierniewice
country: Poland
city: Sobótka
country: Poland
city: Wroclaw
country: Poland
city: Caguas
country: Puerto Rico
city: Carolina
country: Puerto Rico
city: Bucuresti
country: Romania
city: Buzau
country: Romania
city: Cluj-napoca
country: Romania
city: Ploiesti
country: Romania
city: Ploiesti
country: Romania
city: Levice
country: Slovakia
city: Presov
country: Slovakia
city: Samorin
country: Slovakia
city: Trebisov
country: Slovakia
city: Trencin
country: Slovakia
city: Cape Town
country: South Africa
city: Pretoria
country: South Africa
city: Bacarot Alicant
country: Spain
state: Alicante
city: Almeria
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Ljungby
country: Sweden
city: Stockholm
country: Sweden
city: Örebro
country: Sweden
city: Basel
country: Switzerland
city: Geneve
country: Switzerland
city: Zürich
country: Switzerland
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
city: Bangkok
country: Thailand
city: Songkla
country: Thailand
city: Istanbul
country: Turkey
city: Bexhill on Sea
country: United Kingdom
city: Crawley
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Hinckley
country: United Kingdom
city: Reading
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: