Clinical trial NCT01051011: A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy
Official title: A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 370
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 randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age
* type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for \>/= 12 weeks prior to screening
* HbA1c 7-10% at screening
* body weight stable (+/-5%) for \>/= 12 weeks prior to screening
* fasting C-peptide \>/=1ng/ml
* treatment-naïve for insulin

Exclusion Criteria:

* diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
* acute metabolic diabetic complications or evidence of clinically significant diabetic complications
* clinically symptomatic gastrointestinal disease
* history of chronic pancreatitis or acute idiopathic pancreatitis
* \>3 episodes of severe hypoglycemia within 6 months prior to screening
* miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
* any treatment with exenatide, exendin analogues, GLP-1 or its analogues

Primary outcomes:
measure: Glycemic control assessed by HbA1c
timeFrame: week 24
Secondary outcomes:
measure: Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c
timeFrame: week 24
measure: Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)
timeFrame: week 24
measure: Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters
timeFrame: throughout study, laboratory assessments weeks 12, 24, 32 and 52
measure: Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values
timeFrame: week 24
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijng
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hefei
country: China
city: Nanjing
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Shanghai
country: China
city: Shi Jiazhuang
country: China
city: Tianjin (天津)
country: China
city: Tianjin
country: China
city: Hong Kong
country: Hong Kong
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Kangwon-do
country: Korea, Republic of
city: Kyounggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Johor Bahru
country: Malaysia
city: Kelantan
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Penang
country: Malaysia
city: Putrajaya
country: Malaysia
city: Selangor
country: Malaysia
city: Cebu
country: Philippines
city: Iloilo
country: Philippines
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Pasig
country: Philippines
city: Chia-Yi City
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Nakhonratchasima
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: