Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Sponsor: Boehringer Ingelheim
Listed as NCT00601250, this PHASE3 trial focuses on Diabetes Mellitus, Type 2 and remains completed. Sponsored by Boehringer Ingelheim, it has been updated 7 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
7 versions recorded-
Oct 2025 — Present [monthly]
Completed PHASE3
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Sep 2025 — Oct 2025 [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Jan 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Boehringer Ingelheim
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Afula, Israel , Aguascalientes, Ags., Mexico , Andhra Pradesh, India , Athens, Greece , Bangalore, India , Brno, Czechia , Břeclav, Czechia , Charlotte, United States , Chennai, India , Christchurch, New Zealand and 63 more locations