Clinical trial NCT00717457: 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.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 1189
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 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+ 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 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: Fasting body weight
timeFrame: 24 weeks
measure: Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
timeFrame: 24 weeks
measure: Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
timeFrame: 24 weeks
measure: Beta cell function (proinsulin/insulin ratio)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Haleyville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Escondido
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Orange
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Leandro
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Daytona Beach
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Green Cove Springs
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Niceville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Suwanee
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Lombard
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Munfordville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Royal Oak
country: United States
state: Michigan
city: Jefferson City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Concord
country: United States
state: New Hampshire
city: Trenton
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Whitehouse
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Smithtown
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: West Seneca
country: United States
state: New York
city: Westfield
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Hunters Ville
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Westlake
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Red Lion
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Clemson
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Hickory
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Everett
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Camperdown
country: Australia
state: New South Wales
city: Freemantle
country: Australia
state: Queensland
city: Goiania
country: Brazil
state: GO
city: Belem
country: Brazil
state: PA
city: Curtiba
country: Brazil
state: PR
city: Porto Alegre
country: Brazil
state: RS
city: Mogi Das Cruzes - Sp
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Pointe-Claire
country: Canada
state: Quebec
city: Ballerup
country: Denmark
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Turku
country: Finland
city: Corbeil Essonnes
country: France
city: Dommartin Les Toul
country: France
city: Montpellier
country: France
city: Narbonne
country: France
city: Paris
country: France
city: Salouel
country: France
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Damme
country: Germany
city: Dresden
country: Germany
city: Essen
country: Germany
city: Falkensee
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Ludwigshafen
country: Germany
city: Mainz
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Neuwied
country: Germany
city: Nürnberg
country: Germany
city: Pirna
country: Germany
city: Rhaunen
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Zwenkau
country: Germany
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Guatemala
country: Guatemala
city: Guatemala
country: Guatemala
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Pordenone
country: Italy
state: Friuli-Venezia Giulia
city: Genova
country: Italy
state: Liguria
city: Pavia
country: Italy
state: Lombardia
city: Olbia
country: Italy
state: Sardegna
city: Siena
country: Italy
state: Toscana
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Acapulco
country: Mexico
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Tampico
country: Mexico
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Arequipa
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Ponce
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: Barnaul
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: S. Petersburg
country: Russian Federation
city: S.Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Cape Town
country: South Africa
city: Pretoria
country: South Africa
city: Bacarot Alicant
country: Spain
state: Alicante
city: Alzira
country: Spain
state: Valencia
city: Almeria
country: Spain
city: Madrid
country: Spain
city: Karlstad
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Örebro
country: Sweden
city: Zürich
country: Switzerland
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Dnipropetrovs'k
country: Ukraine
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
city: Bath
country: United Kingdom
city: Bradford on Avon
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Lanarkshire
country: United Kingdom
city: Trowbridge
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.