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
Public ClinicalTrials.gov record NCT01183013. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.
Study identification
- NCT ID
- NCT01183013
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 936 participants
Conditions and interventions
Conditions
Interventions
- Pioglitazone 15 mg Drug
- Pioglitazone 45 mg Drug
- Pioglitazone 30 mg Drug
- Linagliptin 5mg / Pioglitazone 45 mg FDC Drug
- Linagliptin 5mg / Pioglitazone 30 mg FDC Drug
- Linagliptin 5mg Drug
- Linagliptin 5mg / Pioglitazone 15 mg FDC Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2010 (Type not available)
- Primary completion
- Feb 2013 (Actual)
- Completion
- Feb 2013 (Actual)
- Last update posted
- Oct 20, 2014
2010 – 2013
United States locations
- U.S. sites
- 74
- U.S. states
- 23
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1264.3.01026 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 1264.3.01021 Boehringer Ingelheim Investigational Site | Montgomery | Alabama | — | — |
| 1264.3.01020 Boehringer Ingelheim Investigational Site | Muscle Shoals | Alabama | — | — |
| 1264.3.01062 Boehringer Ingelheim Investigational Site | Chandler | Arizona | — | — |
| 1264.3.01064 Boehringer Ingelheim Investigational Site | Mesa | Arizona | — | — |
| 1264.3.01049 Boehringer Ingelheim Investigational Site | Carmichael | California | — | — |
| 1264.3.01078 Boehringer Ingelheim Investigational Site | Chino | California | — | — |
| 1264.3.01031 Boehringer Ingelheim Investigational Site | Concord | California | — | — |
| 1264.3.01037 Boehringer Ingelheim Investigational Site | Lakewood | California | — | — |
| 1264.3.01065 Boehringer Ingelheim Investigational Site | Los Angeles | California | — | — |
| 1264.3.01006 Boehringer Ingelheim Investigational Site | Norwalk | California | — | — |
| 1264.3.01001 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California | — | — |
| 1264.3.01059 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1264.3.01023 Boehringer Ingelheim Investigational Site | Tarzana | California | — | — |
| 1264.3.01016 Boehringer Ingelheim Investigational Site | Tustin | California | — | — |
| 1264.3.01058 Boehringer Ingelheim Investigational Site | Valencia | California | — | — |
| 1264.3.01083 Boehringer Ingelheim Investigational Site | Westlake Village | California | — | — |
| 1264.3.01027 Boehringer Ingelheim Investigational Site | Denver | Colorado | — | — |
| 1264.3.01033 Boehringer Ingelheim Investigational Site | Norwalk | Connecticut | — | — |
| 1264.3.01035 Boehringer Ingelheim Investigational Site | Boca Raton | Florida | — | — |
| 1264.3.01015 Boehringer Ingelheim Investigational Site | Clearwater | Florida | — | — |
| 1264.3.01082 Boehringer Ingelheim Investigational Site | Hialeah | Florida | — | — |
| 1264.3.01036 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 1264.3.01013 Boehringer Ingelheim Investigational Site | Longwood | Florida | — | — |
| 1264.3.01038 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1264.3.01042 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1264.3.01079 Boehringer Ingelheim Investigational Site | Miami | Florida | — | — |
| 1264.3.01019 Boehringer Ingelheim Investigational Site | Port Orange | Florida | — | — |
| 1264.3.01018 Boehringer Ingelheim Investigational Site | Saint Cloud | Florida | — | — |
| 1264.3.01009 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1264.3.01012 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1264.3.01008 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1264.3.01055 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1264.3.01061 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1264.3.01074 Boehringer Ingelheim Investigational Site | Blue Ridge | Georgia | — | — |
| 1264.3.01084 Boehringer Ingelheim Investigational Site | Cartersville | Georgia | — | — |
| 1264.3.01060 Boehringer Ingelheim Investigational Site | Perry | Georgia | — | — |
| 1264.3.01050 Boehringer Ingelheim Investigational Site | Savannah | Georgia | — | — |
| 1264.3.01077 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 1264.3.01052 Boehringer Ingelheim Investigational Site | Brownsburg | Indiana | — | — |
| 1264.3.01075 Boehringer Ingelheim Investigational Site | Evansville | Indiana | — | — |
| 1264.3.01076 Boehringer Ingelheim Investigational Site | Evansville | Indiana | — | — |
| 1264.3.01073 Boehringer Ingelheim Investigational Site | Franklin | Indiana | — | — |
| 1264.3.01002 Boehringer Ingelheim Investigational Site | Wichita | Kansas | — | — |
| 1264.3.01007 Boehringer Ingelheim Investigational Site | Wichita | Kansas | — | — |
| 1264.3.01010 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | — | — |
| 1264.3.01028 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | — | — |
| 1264.3.01029 Boehringer Ingelheim Investigational Site | Sunset | Louisiana | — | — |
| 1264.3.01069 Boehringer Ingelheim Investigational Site | Hyattsville | Maryland | — | — |
| 1264.3.01066 Boehringer Ingelheim Investigational Site | Southfield | Michigan | — | — |
| 1264.3.01057 Boehringer Ingelheim Investigational Site | Great Falls | Montana | — | — |
| 1264.3.01045 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | — | — |
| 1264.3.01044 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | — | — |
| 1264.3.01022 Boehringer Ingelheim Investigational Site | Zanesville | Ohio | — | — |
| 1264.3.01032 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1264.3.01051 Boehringer Ingelheim Investigational Site | Fleetwood | Pennsylvania | — | — |
| 1264.3.01025 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 1264.3.01081 Boehringer Ingelheim Investigational Site | Columbia | South Carolina | — | — |
| 1264.3.01003 Boehringer Ingelheim Investigational Site | Greer | South Carolina | — | — |
| 1264.3.01011 Boehringer Ingelheim Investigational Site | Kingsport | Tennessee | — | — |
| 1264.3.01017 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | — | — |
| 1264.3.01067 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1264.3.01004 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1264.3.01039 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1264.3.01041 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1264.3.01047 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1264.3.01070 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1264.3.01040 Boehringer Ingelheim Investigational Site | Killeen | Texas | — | — |
| 1264.3.01048 Boehringer Ingelheim Investigational Site | Midland | Texas | — | — |
| 1264.3.01030 Boehringer Ingelheim Investigational Site | New Braunfels | Texas | — | — |
| 1264.3.01071 Boehringer Ingelheim Investigational Site | North Richland Hills | Texas | — | — |
| 1264.3.01085 Boehringer Ingelheim Investigational Site | Plano | Texas | — | — |
| 1264.3.01046 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1264.3.01056 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01183013, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2014 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01183013 live on ClinicalTrials.gov.