Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Overview[ - collapse ][ - ]
Purpose | Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: linagliptin2.5mg/metformin1000mg Drug: linagliptin2.5mg/metformin1000mg Drug: linagliptin 5mg Drug: Metformin 500mg Drug: linagliptin2.5mg/metformin500mg Drug: linagliptin2.5mg/metformin500mg Drug: linagliptin 5mg Drug: Metformin 1000mg |
Phase | Phase 3 |
Sponsor | Boehringer Ingelheim |
Responsible Party | Boehringer Ingelheim |
ClinicalTrials.gov Identifier | NCT01708902 |
First Received | October 16, 2012 |
Last Updated | April 16, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 16, 2012 |
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Last Updated Date | April 16, 2014 |
Start Date | October 2012 |
Estimated Primary Completion Date | April 2014 |
Current Primary Outcome Measures | The change from baseline in HbA1c after 24 weeks of treatment (for both in main group and additional parallel group). [Time Frame: 24 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients |
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Official Title | A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control |
Brief Summary | Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: linagliptin2.5mg/metformin1000mg linagliptin2.5mg/metformin1000mg BID Drug: linagliptin2.5mg/metformin1000mg linagliptin2.5mg/metformin1000mg BID Drug: linagliptin 5mg linagliptin 5mg once daily Drug: Metformin 500mg Metformin 500mg BID Drug: linagliptin2.5mg/metformin500mg linagliptin2.5mg/metformin500mg BID Drug: linagliptin2.5mg/metformin500mg linagliptin2.5mg/metformin500mg BID Drug: linagliptin 5mg linagliptin 5mg once daily Drug: Metformin 1000mg Metformin 1000mg BID |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 876 |
Estimated Completion Date | April 2014 |
Estimated Primary Completion Date | April 2014 |
Eligibility Criteria | Inclusion criteria: 1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-naïve 3. Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 %<11% for main group and HbA1c >/= 11.0 % for the additional parallel group 4. Age >/= 18 and = 80 years at Visit 1a (Screening) 5. Body Mass Index(BMI) = 40 kg/m2 at Visit 1a (Screening) 6. Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation Exclusion criteria: 1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase 2. In main group, the patients with investigational medicinal product(IMP) compliance < 80 % or >120 % during 2 weeks placebo run in period 3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation 4. Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a 5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo 6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening 7. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator. 8. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial. 9. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study 10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) < 60 ml/min 12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 13. Dehydration by clinical judgement of the investigator 14. Clinical detected unstable or acute congestive heart failure 15. Acute or chronic metabolic acidosis (present in patient history) 16. Hereditary galactose intolerance 17. Known history of pancreatitis and chronic pancreatitis 18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years. 19. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China, Malaysia, Philippines, Vietnam |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01708902 |
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Other Study ID Numbers | 1288.18 |
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 | April 2014 |
Locations[ + expand ][ + ]
1288.18.86001 Boehringer Ingelheim Investigational Site | Beijing, China |
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1288.18.86002 Boehringer Ingelheim Investigational Site | Beijing, China |
1288.18.86003 Boehringer Ingelheim Investigational Site | Beijing, China |
1288.18.86046 Boehringer Ingelheim Investigational Site | Beijing, China |
1288.18.86004 Boehringer Ingelheim Investigational Site | Beijing, China |
1288.18.86019 Boehringer Ingelheim Investigational Site | Changchun, China |
1288.18.86020 Boehringer Ingelheim Investigational Site | Changchun, China |
1288.18.86050 Boehringer Ingelheim Investigational Site | Changsha, China |
1288.18.86029 Boehringer Ingelheim Investigational Site | Changsha, China |
1288.18.86028 Boehringer Ingelheim Investigational Site | Changsha, China |
1288.18.86045 Boehringer Ingelheim Investigational Site | Chengdu, China |
1288.18.86042 Boehringer Ingelheim Investigational Site | Chongqing, China |
1288.18.86023 Boehringer Ingelheim Investigational Site | Dalian, China |
1288.18.86009 Boehringer Ingelheim Investigational Site | Guangzhou, China |
1288.18.86010 Boehringer Ingelheim Investigational Site | Guangzhou, China |
1288.18.86012 Boehringer Ingelheim Investigational Site | Guangzhou, China |
1288.18.86047 Boehringer Ingelheim Investigational Site | Haerbin, China |
1288.18.86032 Boehringer Ingelheim Investigational Site | Hefei, China |
1288.18.86016 Boehringer Ingelheim Investigational Site | Hengshui, China |
1288.18.86017 Boehringer Ingelheim Investigational Site | Jinan, China |
1288.18.86026 Boehringer Ingelheim Investigational Site | Lanzhou, China |
1288.18.86034 Boehringer Ingelheim Investigational Site | Nan Ning, China |
1288.18.86039 Boehringer Ingelheim Investigational Site | Nanchang, China |
1288.18.86035 Boehringer Ingelheim Investigational Site | Nanjing, China |
1288.18.86036 Boehringer Ingelheim Investigational Site | Nanjing, China |
1288.18.86008 Boehringer Ingelheim Investigational Site | Shanghai, China |
1288.18.86006 Boehringer Ingelheim Investigational Site | Shanghai, China |
1288.18.86007 Boehringer Ingelheim Investigational Site | Shanghai, China |
1288.18.86013 Boehringer Ingelheim Investigational Site | Shantou, China |
1288.18.86022 Boehringer Ingelheim Investigational Site | Shenyang, China |
1288.18.86014 Boehringer Ingelheim Investigational Site | Shijiazhuang, China |
1288.18.86015 Boehringer Ingelheim Investigational Site | Shijiazhuang, China |
1288.18.86038 Boehringer Ingelheim Investigational Site | Suzhou, China |
1288.18.86049 Boehringer Ingelheim Investigational Site | Wuhan, China |
1288.18.86033 Boehringer Ingelheim Investigational Site | Wuhu, China |
1288.18.86024 Boehringer Ingelheim Investigational Site | Xi'An, China |
1288.18.86025 Boehringer Ingelheim Investigational Site | Xi'An, China |
1288.18.86030 Boehringer Ingelheim Investigational Site | Yueyang, China |
1288.18.60004 Boehringer Ingelheim Investigational Site | Kelantan, Malaysia |
1288.18.60002 Boehringer Ingelheim Investigational Site | Melaka, Malaysia |
1288.18.60007 Boehringer Ingelheim Investigational Site | Negeri Sembilan, Malaysia |
1288.18.60005 Boehringer Ingelheim Investigational Site | Negeri Sembilan, Malaysia |
1288.18.60006 Boehringer Ingelheim Investigational Site | Perak, Malaysia |
1288.18.60001 Boehringer Ingelheim Investigational Site | Perak, Malaysia |
1288.18.60008 Boehringer Ingelheim Investigational Site | Putrajaya, Malaysia |
1288.18.60003 Boehringer Ingelheim Investigational Site | Selangor, Malaysia |
1288.18.63007 Boehringer Ingelheim Investigational Site | Cebu, Philippines |
1288.18.63003 Boehringer Ingelheim Investigational Site | Cebu City, Philippines |
1288.18.63002 Boehringer Ingelheim Investigational Site | Makati City, Philippines |
1288.18.63001 Boehringer Ingelheim Investigational Site | Manila, Philippines |
1288.18.63008 Boehringer Ingelheim Investigational Site | Quezon City, Philippines |
1288.18.63006 Boehringer Ingelheim Investigational Site | Surigao, Philippines |
1288.18.63005 Boehringer Ingelheim Investigational Site | Tagum City, Philippines |
1288.18.84003 Boehringer Ingelheim Investigational Site | Hanoi, Vietnam |
1288.18.84002 Boehringer Ingelheim Investigational Site | Ho Chi Minh City, Vietnam |
1288.18.84001 Boehringer Ingelheim Investigational Site | Ho Chi Minh City, Vietnam |