Clinical trial NCT00744926: A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
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: 373
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. 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 year, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
* tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
* C-peptide (fasting) \>=1.0ng/mL
* HbA1c \>=6.5% 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;
* 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: Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
timeFrame: Throughout study
measure: Change from baseline in fasting plasma glucose; change from baseline in body weight.
timeFrame: 24 weeks
measure: Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Avon
country: United States
state: Indiana
city: Pahrump
country: United States
state: Nevada
city: Charlotte
country: United States
state: North Carolina
city: Greer
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Adelaide
country: Australia
city: St. Leonards
country: Australia
city: Guatemala
country: Guatemala
city: Guatemala
country: Guatemala
city: Haifa
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: Tel Aviv
country: Israel
city: Acapulco
country: Mexico
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Hermosillo
country: Mexico
city: Mexico City
country: Mexico
city: Morelia
country: Mexico
city: Lima
country: Peru
city: San Isidro
country: Peru
city: Bucuresti
country: Romania
city: Buzau
country: Romania
city: Cluj-napoca
country: Romania
city: Ploiesti
country: Romania
city: Ploiesti
country: Romania
city: Tg. Mures
country: Romania
city: Chelyabinsk
country: Russian Federation
city: Jaloslave
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: S. Petersburg
country: Russian Federation
city: S.petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Dolny Kubin
country: Slovakia
city: Levice
country: Slovakia
city: Presov
country: Slovakia
city: Trencin
country: Slovakia
city: Zilina
country: Slovakia
city: Changhua
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Tapei County
country: Taiwan
city: Chernovtsy
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: