30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise
Sponsor: Boehringer Ingelheim
Listed as NCT01183013, this PHASE3 trial focuses on Diabetes Mellitus, Type 2 and remains completed. Sponsored by Boehringer Ingelheim, it has been updated 7 times since 2010, 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-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jan 2021 — Dec 2021 [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
Aug 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Boehringer Ingelheim
- Eli Lilly and Company
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Annan, United Kingdom , Ash Vale, Aldershot, United Kingdom , Atlanta, United States , Bad Lauterberg / Harz, Germany , Badía Del Vallès - Barcelona, Spain , Baillieston, Glasgow, United Kingdom , Balham, United Kingdom , Barcelona, Spain , Birmingham, United States , Blue Ridge, United States and 99 more locations