Clinical trial NCT00744367: A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-01
Enrollment: 326
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 of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks 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 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years age;
* type 2 diabetes receiving pioglitazone (\>= 30 mg/day) and metformin (\>= 1500 mg/day) for at least 12 weeks prior to screening;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>= 25 (\>23 for Asians) and \<=45 kg/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: 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%); responder rates for body weight; beta cell function.
timeFrame: 24 weeks
measure: Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Buena Park
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Wheatridge
country: United States
state: Colorado
city: Hamden
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Chiefland
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Nampa
country: United States
state: Idaho
city: Aurora
country: United States
state: Illinois
city: Libertyville
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Frederick
country: United States
state: Maryland
city: Oxon Hill
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Ferndale
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Olive Branch
country: United States
state: Mississippi
city: St Peters
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Hudson
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Athens
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Carlisle
country: United States
state: Pennsylvania
city: Levittown
country: United States
state: Pennsylvania
city: Melrose Park
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Cranston
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Bellaire
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: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Federal Way
country: United States
state: Washington
city: Brasilia
country: Brazil
city: Forlateza
country: Brazil
city: Fortaleza
country: Brazil
city: Fortaleza
country: Brazil
city: Fortaleza
country: Brazil
city: Mogi Das Cruzes - Sp
country: Brazil
city: Passo Fundo
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Pointe-claire
country: Canada
state: Quebec
city: San Jose
country: Costa Rica
city: Bondy
country: France
city: Dijon
country: France
city: Nantes
country: France
city: Narbonne
country: France
city: Falkensee
country: Germany
city: Karlsruhe
country: Germany
city: Mainz
country: Germany
city: Neuwied
country: Germany
city: Potsdam
country: Germany
city: Guatemala
country: Guatemala
city: Guatemala
country: Guatemala
city: Chihuahua
country: Mexico
city: Jalisco
country: Mexico
city: Mexico City
country: Mexico
city: Carolina
country: Puerto Rico
city: Guyanabo, San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: