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
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: taspoglutide Drug: taspoglutide Drug: insulin glargine Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Hoffmann-La Roche |
| Responsible Party | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier | NCT01051011 |
| First Received | January 15, 2010 |
| Last Updated | April 14, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 15, 2010 |
|---|---|
| Last Updated Date | April 14, 2014 |
| Start Date | January 2010 |
| Estimated Primary Completion Date | December 2010 |
| Current Primary Outcome Measures | Glycemic control assessed by HbA1c [Time Frame: week 24] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 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. |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: taspoglutide 10mg sc weekly, 24 (-52) weeks Drug: taspoglutide 10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks Drug: insulin glargine initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks Drug: metformin as prescribed |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 370 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | December 2010 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China, Hong Kong, Korea, Republic of, Malaysia, Philippines, Taiwan, Thailand |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01051011 |
|---|---|
| Other Study ID Numbers | ZC22565 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hoffmann-La Roche |
| Study Sponsor | Hoffmann-La Roche |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Trials Hoffmann-La Roche |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| China | Beijing, China, 100029 |
|---|---|
| China | Beijing, China, 100853 |
| China | Beijing, China, 100730 |
| China | Beijng, China, 100700 |
| China | Chengdu, China, 610041 |
| China | Chongqing, China, 400010 |
| China | Guangzhou, China, 510120 |
| China | Hangzhou, China, 310009 |
| China | Hefei, China, 230022 |
| China | Nanjing, China, 210029 |
| China | Nanjing, China, 210006 |
| China | Nanning, China, 530021 |
| China | Shanghai, China, 200080 |
| China | Shijiazhuang, China, 050051 |
| China | Tianjin, China, 300052 |
| China | Tianjin, China, 201203 |
| Hong Kong | Hong Kong, Hong Kong |
| Korea, Republic of | Busan, Korea, Republic of, 614-735 |
| Korea, Republic of | Daegu, Korea, Republic of, 705-717 |
| Korea, Republic of | Daegu, Korea, Republic of, 705-718 |
| Korea, Republic of | Gyeonggi-do, Korea, Republic of, 410-773 |
| Korea, Republic of | Gyeonggi-do, Korea, Republic of, 443-380 |
| Korea, Republic of | Gyeonggi-do, Korea, Republic of, 463-712 |
| Korea, Republic of | Incheon, Korea, Republic of, 405-760 |
| Korea, Republic of | Kangwon-do, Korea, Republic of, 220-701 |
| Korea, Republic of | Kyounggi-do, Korea, Republic of, 420-717 |
| Korea, Republic of | Seoul, Korea, Republic of, 139-872 |
| Korea, Republic of | Seoul, Korea, Republic of, 110-746 |
| Korea, Republic of | Seoul, Korea, Republic of, 137-701 |
| Korea, Republic of | Seoul, Korea, Republic of |
| Korea, Republic of | Seoul, Korea, Republic of, 135-720 |
| Korea, Republic of | Seoul, Korea, Republic of, 130-702 |
| Korea, Republic of | Seoul, Korea, Republic of, 134-701 |
| Malaysia | Johor Bahru, Malaysia, 80200 |
| Malaysia | Kelantan, Malaysia, 16150 |
| Malaysia | Kuala Lumpur, Malaysia, 50586 |
| Malaysia | Kuala Lumpur, Malaysia, 50603 |
| Malaysia | Penang, Malaysia, 10450 |
| Malaysia | Putrajaya, Malaysia, 62250 |
| Malaysia | Selangor, Malaysia |
| Philippines | Cebu, Philippines, 6000 |
| Philippines | Iloilo, Philippines, 5000 |
| Philippines | Manila, Philippines, 1357 |
| Philippines | Manila, Philippines, 1000 |
| Philippines | Manila, Philippines, 1503 |
| Philippines | Pasig, Philippines, 1605 |
| Taiwan | Chia-Yi City, Taiwan, 60002 |
| Taiwan | Taichung, Taiwan, 404 |
| Taiwan | Tainan, Taiwan, 710 |
| Taiwan | Taipei, Taiwan, 00112 |
| Taiwan | Taipei, Taiwan, 220 |
| Taiwan | Taoyuan County, Taiwan, 333 |
| Thailand | Bangkok, Thailand, 10400 |
| Thailand | Bangkok, Thailand, 10330 |
| Thailand | Chiang Mai, Thailand, 50200 |
| Thailand | Nakhonratchasima, Thailand, 30000 |