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
NCT ID: NCT01051011
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
370 participants
INTERVENTIONAL
2010-01-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
metformin
as prescribed
taspoglutide
10mg sc weekly, 24 (-52) weeks
2
metformin
as prescribed
taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
3
insulin glargine
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
metformin
as prescribed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin glargine
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
metformin
as prescribed
taspoglutide
10mg sc weekly, 24 (-52) weeks
taspoglutide
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing, , China
Beijing, , China
Beijing, , China
Beijng, , China
Chengdu, , China
Chongqing, , China
Guangzhou, , China
Hangzhou, , China
Hefei, , China
Nanjing, , China
Nanjing, , China
Nanning, , China
Shanghai, , China
Shijiazhuang, , China
Tianjin, , China
Tianjin (天津), , China
Hong Kong, , Hong Kong
George Town, , Malaysia
Johor Bahru, , Malaysia
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Selangor, , Malaysia
Putrajaya, , Malaysia
Cebu, , Philippines
Iloilo City, , Philippines
Manila, , Philippines
Manila, , Philippines
Manila, , Philippines
Pasig, , Philippines
Busan, , South Korea
Daegu, , South Korea
Daegu, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Kangwon-do, , South Korea
Kyounggi-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Chia-Yi City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Nakhonratchasima, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZC22565
Identifier Type: -
Identifier Source: org_study_id