Clinical trial NCT00909597: A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
Official title: A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 756
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 double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus;
* treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for \>=12 weeks prior to screening;
* HbA1c \>=7.0% and \<=10% at screening;
* stable weight +/-5% for \>=12 weeks prior to screening.

Exclusion Criteria:

* type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
* clinically significant diabetic complications;
* clinically symptomatic gastrointestinal disease;
* \>3 episodes of severe hypoglycemia within 6 months before screening.

Primary outcomes:
measure: Absolute change from baseline in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of patients achieving target HbA1c <=6.5%, <=7%
timeFrame: weeks 24, 52 and 104
measure: Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose
timeFrame: weeks 24, 52 and 104
measure: Adverse events; laboratory parameters; cardiovascular events
timeFrame: At each clinic visit up to 106 weeks
Other outcomes:
Locations:
city: Buena Park
country: United States
state: California
city: Chino
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Roseville
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Chiefland
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Madisonville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Bethesda
country: United States
state: Maryland
city: Ayer
country: United States
state: Massachusetts
city: Waltham
country: United States
state: Massachusetts
city: Ferndale
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Biloxi
country: United States
state: Mississippi
city: Jackson
country: United States
state: Mississippi
city: Olive Branch
country: United States
state: Mississippi
city: Grand Island
country: United States
state: Nebraska
city: Berlin
country: United States
state: New Jersey
city: Brick
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Trenton
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Bend
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: South Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Waukesha
country: United States
state: Wisconsin
city: Camperdown
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Fortaleza
country: Brazil
state: CE
city: Lago sul
country: Brazil
state: DF
city: Belo Horizonte
country: Brazil
state: MG
city: Marilia
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
city: Vancouver
country: Canada
state: British Columbia
city: Etobicoke
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Thornhill
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: San Jose
country: Costa Rica
city: San Jose
country: Costa Rica
city: Besancon
country: France
city: Corbeil Essonnes
country: France
city: Dommartin Les Toul
country: France
city: La Rochelle
country: France
city: Lille
country: France
city: Poitiers
country: France
city: Venissieux
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Falkensee
country: Germany
city: Mainz
country: Germany
city: Münster
country: Germany
city: Rodgau
country: Germany
city: Siegen
country: Germany
city: Sulzbach-Rosenberg
country: Germany
city: Wangen
country: Germany
city: Aguascaliente
country: Mexico
city: Celaya
country: Mexico
city: Cuernavaca
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico-City
country: Mexico
city: Monterrey
country: Mexico
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: San Isidro
country: Peru
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Wroclaw
country: Poland
city: Rio Piedras
country: Puerto Rico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Penza
country: Russian Federation
city: S.Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-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: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Bratislava
country: Slovakia
city: Dolny Kubin
country: Slovakia
city: Levice
country: Slovakia
city: Levice
country: Slovakia
city: Cape Town
country: South Africa
city: Oviedo
country: Spain
state: Asturias
city: Pamplona
country: Spain
state: Navarra
city: Barakaldo
country: Spain
state: Vizcaya
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Chiang Mai
country: Thailand
city: Pathumthani
country: Thailand
city: Songkla
country: Thailand
city: Kiev
country: Ukraine
city: Odessa
country: Ukraine
city: Odessa
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Atherstone
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: Dumfries
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: