Clinical trial NCT00755287: 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.
Official 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
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: 1072
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 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 2+ years, and the target sample size if 500+ individuals.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change from baseline 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%); incidence of hypoglycemia; change from baseline in lipid profile.
timeFrame: 24 weeks
measure: Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.
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: Phoenix
country: United States
state: Arizona
city: Searcy
country: United States
state: Arkansas
city: Concord
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Green Cove Springs
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Trinity
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Quincy
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Avon
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Arkansas City
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Sunset
country: United States
state: Louisiana
city: Portland
country: United States
state: Maine
city: North East
country: United States
state: Maryland
city: Worchester
country: United States
state: Massachusetts
city: St. Claire Shores
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Picayune
country: United States
state: Mississippi
city: Springfield
country: United States
state: Missouri
city: Grand Island
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Henderson
country: United States
state: Nevada
city: Blackwood
country: United States
state: New Jersey
city: Cherry Hill
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Centerville
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Genoa
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Altoona
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Feasterville
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Jefferson Hills
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: Orangeburg
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
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: Richmond
country: United States
state: Virginia
city: Waukesha
country: United States
state: Wisconsin
city: St. Leonards
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Freemantle
country: Australia
state: Queensland
city: Graz
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Arlon
country: Belgium
city: Bonheiden
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Recife
country: Brazil
state: PE
city: Campina Grande do Sul
country: Brazil
state: PR
city: Curitiba
country: Brazil
state: PR
city: Porto Alegre
country: Brazil
state: RS
city: Sao Paulo
country: Brazil
state: SP
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Pointe-Claire
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Brno
country: Czech Republic
city: Havirov
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha
country: Czech Republic
city: Trutnov
country: Czech Republic
city: Helsinki
country: Finland
city: Jyvaeskylae
country: Finland
city: Tampere
country: Finland
city: Avignon
country: France
city: Besancon
country: France
city: Bois Guillaume
country: France
city: Brest
country: France
city: Corbeil Essonnes
country: France
city: La Rochelle
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nimes
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Venissieux
country: France
city: Bad Lauterberg
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bosenheim
country: Germany
city: Dortmund
country: Germany
city: Falkensee
country: Germany
city: Freiburg
country: Germany
city: Mainz
country: Germany
city: Offenbach a.M.
country: Germany
city: Reichenbach
country: Germany
city: Würzburg
country: Germany
city: Athens
country: Greece
city: Larissa
country: Greece
city: Thessaloniki
country: Greece
city: Guatemala
country: Guatemala
city: Hong Kong
country: Hong Kong
city: Balatonfuered
country: Hungary
city: Budapest
country: Hungary
city: Szekszard
country: Hungary
city: Napoli
country: Italy
state: Campania
city: Roma
country: Italy
state: Lazio
city: Codogno
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Daegu
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Aguascalientes
country: Mexico
city: Cuernavaca
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: Trujillo
country: Peru
city: Grodzisk Mazowiecki
country: Poland
city: Kamieniec Zabkowicki
country: Poland
city: Lodz
country: Poland
city: Rzeszow
country: Poland
city: Sobótka
country: Poland
city: Szczecin
country: Poland
city: Wroclaw
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Guyanabo, San Juan
country: Puerto Rico
city: Levittown
country: Puerto Rico
city: Orocovis
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Trujillo Alto
country: Puerto Rico
city: Barnaul
country: Russian Federation
city: Chelyabinsk
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: Omsk
country: Russian Federation
city: Saint-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: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: Pozuelo de alarcon
country: Spain
state: Madrid
city: Alzira
country: Spain
state: Valencia
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Atherstone
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: Dumfries
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Trowbridge
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.