Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
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1 Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control Status: Completed Study Phase: Phase 3 Start Date: February 2008 Completion Date: May 2009 Condition(s): Diabetes Mellitus, Type 2 Full Title of Study A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control Overview To investigate efficacy, safety and tolerability of BI 1356 versus placebo Study Details Study Type: Interventional Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment Investigator Details Lead Sponsor: Boehringer Ingelheim Study Chair: Boehringer Ingelheim Boehringer Ingelheim Trial Location Details
2 Facility: Boehringer Ingelheim Investigational Site Krapinske Toplice, Croatia Facility: Boehringer Ingelheim Investigational Site Slavonski Brod, Croatia Facility: Boehringer Ingelheim Investigational Site Andhra Pradesh, India Facility: Boehringer Ingelheim Investigational Site Bangalore, India Facility: Boehringer Ingelheim Investigational Site Bangalore, India Facility: Boehringer Ingelheim Investigational Site Chennai, India Facility: Boehringer Ingelheim Investigational Site Ghaziabad, India Facility: Boehringer Ingelheim Investigational Site Hyderabad, India Facility: Boehringer Ingelheim Investigational Site Jaipur, India Facility: Boehringer Ingelheim Investigational Site Maharashtra, India Facility: Boehringer Ingelheim Investigational Site Mangalore, India Facility: Boehringer Ingelheim Investigational Site Manipal, India Facility: Boehringer Ingelheim Investigational Site Mumbai, India Facility: Boehringer Ingelheim Investigational Site Nasik, India Facility: Boehringer Ingelheim Investigational Site Tamilnadu, India Facility: Boehringer Ingelheim Investigational Site Trivandrum, Kerala, India Facility: Boehringer Ingelheim Investigational Site Givataim, Israel Facility: Boehringer Ingelheim Investigational Site Haifa, Israel Facility: Boehringer Ingelheim Investigational Site Holon, Israel Facility: Boehringer Ingelheim Investigational Site Jerusalem, Israel Facility: Boehringer Ingelheim Investigational Site Nahariya, Israel Facility: Boehringer Ingelheim Investigational Site Safed, Israel Facility: Boehringer Ingelheim Investigational Site Catanzaro, Italy Facility: Boehringer Ingelheim Investigational Site Genova, Italy Facility: Boehringer Ingelheim Investigational Site Milano, Italy Facility: Boehringer Ingelheim Investigational Site Pisa, Italy Facility: Boehringer Ingelheim Investigational Site Roma, Italy Facility: Boehringer Ingelheim Investigational Site Alor Star, Malaysia
3 Facility: Boehringer Ingelheim Investigational Site Kelantan Kota Bahru, Malaysia Facility: Boehringer Ingelheim Investigational Site Kuala Lumpur, Malaysia Facility: Boehringer Ingelheim Investigational Site Kuala Lumpur, Malaysia Facility: Boehringer Ingelheim Investigational Site Perak, Malaysia Facility: Boehringer Ingelheim Investigational Site Perak, Malaysia Facility: Boehringer Ingelheim Investigational Site Pulau Pinang, Malaysia Facility: Boehringer Ingelheim Investigational Site Andijk, Netherlands Facility: Boehringer Ingelheim Investigational Site Castricum, Netherlands Facility: Boehringer Ingelheim Investigational Site Deurne, Netherlands Facility: Boehringer Ingelheim Investigational Site Ewijk, Netherlands Facility: Boehringer Ingelheim Investigational Site Losser, Netherlands Facility: Boehringer Ingelheim Investigational Site Oude Pekela, Netherlands Facility: Boehringer Ingelheim Investigational Site Poortvliet, Netherlands Facility: Boehringer Ingelheim Investigational Site Rijswijk, Netherlands Facility: Boehringer Ingelheim Investigational Site Roelofarendsveen, Netherlands Facility: Boehringer Ingelheim Investigational Site Wildervank, Netherlands Facility: Boehringer Ingelheim Investigational Site Lublin, Poland Facility: Boehringer Ingelheim Investigational Site Warsaw, Poland Facility: Boehringer Ingelheim Investigational Site Zabrze, Poland Facility: Boehringer Ingelheim Investigational Site Brasov, Romania Facility: Boehringer Ingelheim Investigational Site Galati, Romania Facility: Boehringer Ingelheim Investigational Site Banska Bystrica, Slovakia Facility: Boehringer Ingelheim Investigational Site Bratislava, Slovakia Facility: Boehringer Ingelheim Investigational Site Bratislava, Slovakia Facility: Boehringer Ingelheim Investigational Site Bratislava, Slovakia Facility: Boehringer Ingelheim Investigational Site Nove Mesto nad Vahom, Slovakia Facility: Boehringer Ingelheim Investigational Site Samorin, Slovakia Facility: Boehringer Ingelheim Investigational Site Bangkok, Thailand
4 Facility: Boehringer Ingelheim Investigational Site Khon Kaen, Thailand Facility: Boehringer Ingelheim Investigational Site Dnepropetrovsk, Ukraine Facility: Boehringer Ingelheim Investigational Site Kharkiv, Ukraine Facility: Boehringer Ingelheim Investigational Site Kharkov, Ukraine Facility: Boehringer Ingelheim Investigational Site Kharkov, Ukraine Facility: Boehringer Ingelheim Investigational Site Kiev, Ukraine Facility: Boehringer Ingelheim Investigational Site Kiev, Ukraine Facility: Boehringer Ingelheim Investigational Site Kiev, Ukraine Facility: Boehringer Ingelheim Investigational Site Kiev, Ukraine Facility: Boehringer Ingelheim Investigational Site Kiev, Ukraine Facility: Boehringer Ingelheim Investigational Site Lvov, Ukraine Facility: Boehringer Ingelheim Investigational Site Vinnitsa, Ukraine Facility: Boehringer Ingelheim Investigational Site Zaporizhzhya, Ukraine Interventions Drug: linagliptin active Drug: placebo placebo Information Source ID Number: NCT Identifier: NCT Health Authority: Array Full Source of Clinical Trial Data: ClinicalTrials.gov processed this data on October 07, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
5 by this site. Please see the full source link above for retrieving further details from the government database.
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