deltatrials
Completed PHASE3 INTERVENTIONAL 7-arm NCT01183013

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

Updated 7 times since 2017 Last updated: Oct 9, 2014 Started: Aug 31, 2010 Primary completion: Feb 28, 2013 Completion: Feb 28, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. 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

Sponsor contact:
  • Boehringer Ingelheim
  • Eli Lilly and Company
Data source: Boehringer Ingelheim

For direct contact, visit the study record on ClinicalTrials.gov .