Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 5, 2009) | Incidence and intensity of AEs; Withdrawal due to AEs; Clinically relevant new or worsening findings in physical examination and 12lead ECG as reported as AE; Changes from baseline in vital signs and clinical laboratory assessments [ Time Frame: 54 weeks ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00915772 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: June 5, 2009) | Change from baseline in HbA1c and FPG after 54 weeks of treatment and FPG by visit over time; Occurrance of a treat to target response that is an HbA1c under treatment of <7% and < 6.5% after 54 weeks of treatment; HbA1c reduction [ Time Frame: 54 weeks ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid |
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Official Title ICMJE | Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid |
Brief Summary | A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46 |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Diabetes Mellitus, Type 2 |
Intervention ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 745 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Canada, Croatia, Estonia, France, Germany, India, Lithuania, Mexico, Netherlands, Romania, Russian Federation, Sweden, Tunisia, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00915772 | ||||
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Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
Study ID Numbers ICMJE | 1218.52, EudraCT2008-008494-59 | ||||
Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals |
Source: http://clinicaltrials.gov/