Comprehensive Add on Study in Japan
Overview[ - collapse ][ - ]
| Purpose | The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Linagliptin Drug: Linagliptin Drug: Metformin Drug: Metformin Drug: Linagliptin Drug: Linagliptin Drug: Linagliptin |
| Phase | Phase 3 |
| Sponsor | Boehringer Ingelheim |
| Responsible Party | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier | NCT01204294 |
| First Received | September 16, 2010 |
| Last Updated | February 27, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 16, 2010 |
|---|---|
| Last Updated Date | February 27, 2014 |
| Start Date | September 2010 |
| Estimated Primary Completion Date | January 2012 |
| Current Primary Outcome Measures | Incidence of Adverse Events (AEs) [Time Frame: The first drug administration through 7 days after the last drug administration, up to 382 days] [Designated as safety issue: Yes]The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events |
| Current Secondary Outcome Measures | Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: Baseline and 52 weeks] [Designated as safety issue: No]The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Comprehensive Add on Study in Japan |
|---|---|
| Official Title | An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug |
| Brief Summary | The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug. |
| 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: Linagliptin Linagliptin once daily Drug: Linagliptin Linagliptin once daily Drug: Metformin Metformin twice or three time per day Drug: Metformin Metformin twice or three time per day Drug: Linagliptin Linagliptin once daily Drug: Linagliptin Linagliptin once daily Drug: Linagliptin Linagliptin once daily |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 574 |
| Estimated Completion Date | January 2012 |
| Estimated Primary Completion Date | January 2012 |
| Eligibility Criteria | Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus 2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug Exclusion criteria: 1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism 2. Impaired hepatic function 3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1 4. Treatment with anti-obesity drugs |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Japan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01204294 |
|---|---|
| Other Study ID Numbers | 1218.78 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Boehringer Ingelheim |
| Study Sponsor | Boehringer Ingelheim |
| Collaborators | Eli Lilly and Company |
| Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| 1218.78.008 Boehringer Ingelheim Investigational Site | Akishima, Tokyo, Japan |
|---|---|
| 1218.78.030 Boehringer Ingelheim Investigational Site | Amagasaki, Hyogo, Japan |
| 1218.78.017 Boehringer Ingelheim Investigational Site | Annaka, Gunma, Japan |
| 1218.78.006 Boehringer Ingelheim Investigational Site | Aomori, Aomori, Japan |
| 1218.78.007 Boehringer Ingelheim Investigational Site | Aomori, Aomori, Japan |
| 1218.78.013 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo, Japan |
| 1218.78.009 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo, Japan |
| 1218.78.040 Boehringer Ingelheim Investigational Site | Fukuoka, Fukuoka, Japan |
| 1218.78.032 Boehringer Ingelheim Investigational Site | Fukuoka, Fukuoka, Japan |
| 1218.78.037 Boehringer Ingelheim Investigational Site | Higashi Osaka, Osaka, Japan |
| 1218.78.043 Boehringer Ingelheim Investigational Site | Hitachinaka, Ibaraki, Japan |
| 1218.78.019 Boehringer Ingelheim Investigational Site | Isesaki, Gunma, Japan |
| 1218.78.036 Boehringer Ingelheim Investigational Site | Kashiwara, Osaka, Japan |
| 1218.78.026 Boehringer Ingelheim Investigational Site | Kasugai, Aichi, Japan |
| 1218.78.038 Boehringer Ingelheim Investigational Site | Kawachinagano, Osaka, Japan |
| 1218.78.021 Boehringer Ingelheim Investigational Site | Kitaazumi-gun, Nagano, Japan |
| 1218.78.033 Boehringer Ingelheim Investigational Site | Matsumoto, Nagano, Japan |
| 1218.78.022 Boehringer Ingelheim Investigational Site | Matsumoto, Nagano, Japan |
| 1218.78.012 Boehringer Ingelheim Investigational Site | Meguro-ku, Tokyo, Japan |
| 1218.78.041 Boehringer Ingelheim Investigational Site | Meguro-ku, Tokyo, Japan |
| 1218.78.035 Boehringer Ingelheim Investigational Site | Morioka, Iwate, Japan |
| 1218.78.034 Boehringer Ingelheim Investigational Site | Morioka, Iwate, Japan |
| 1218.78.018 Boehringer Ingelheim Investigational Site | Moriya, Ibaraki, Japan |
| 1218.78.024 Boehringer Ingelheim Investigational Site | Nagoya, Aichi, Japan |
| 1218.78.031 Boehringer Ingelheim Investigational Site | Nagoya, Aichi, Japan |
| 1218.78.027 Boehringer Ingelheim Investigational Site | Nagoya, Aichi, Japan |
| 1218.78.028 Boehringer Ingelheim Investigational Site | Nagoya, Aichi, Japan |
| 1218.78.025 Boehringer Ingelheim Investigational Site | Nagoya, Aichi, Japan |
| 1218.78.039 Boehringer Ingelheim Investigational Site | Oita, Oita, Japan |
| 1218.78.004 Boehringer Ingelheim Investigational Site | Okinawa, Okinawa, Japan |
| 1218.78.016 Boehringer Ingelheim Investigational Site | Sagae, Yamagata, Japan |
| 1218.78.042 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido, Japan |
| 1218.78.001 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido, Japan |
| 1218.78.020 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido, Japan |
| 1218.78.005 Boehringer Ingelheim Investigational Site | Shimajiri-gun, Okinawa, Japan |
| 1218.78.014 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo, Japan |
| 1218.78.002 Boehringer Ingelheim Investigational Site | Shinjyuku-ku. Tokyo, Japan |
| 1218.78.011 Boehringer Ingelheim Investigational Site | Shizuoka, Shizuoka, Japan |
| 1218.78.003 Boehringer Ingelheim Investigational Site | Suita, Osaka, Japan |
| 1218.78.029 Boehringer Ingelheim Investigational Site | Tokorozawa, Saitama, Japan |
| 1218.78.023 Boehringer Ingelheim Investigational Site | Tokorozawa, Saitama, Japan |
| 1218.78.010 Boehringer Ingelheim Investigational Site | Tsuchiura, Ibaraki, Japan |
| 1218.78.015 Boehringer Ingelheim Investigational Site | Yamagata, Yamagata, Japan |