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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01183013

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.

ClinicalTrials.gov public records Last synced Jul 24, 2026, 7:32 PM EDT

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

Study identification

NCT ID
NCT01183013
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
936 participants

Conditions and interventions

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
Jul 31, 2010
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013
Last update posted
Oct 19, 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 19, 2014 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01183013 live on ClinicalTrials.gov.

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