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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01183013
First received: August 16, 2010
Last updated: June 3, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c After 30 Weeks of Treatment. [ Time Frame: Baseline and 30 weeks ] [ Designated as safety issue: No ]
    HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.


Secondary Outcome Measures:
  • Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment [ Time Frame: Baseline and 30 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

  • Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment [ Time Frame: Baseline and 30 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

  • Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment) [ Time Frame: Baseline and 30 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.

  • HbA1c Change From Baseline by Visit Over Time [ Time Frame: Baseline, week 6, week 12, week 18, week 24, week 30 ] [ Designated as safety issue: No ]

    HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.

    by visit interaction.


  • Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment [ Time Frame: Baseline and 30 weeks ] [ Designated as safety issue: No ]
    The change from baseline is the FPG after 30 weeks minus the baseline FPG.

  • Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time [ Time Frame: Baseline, week 6, week 12, week 18, week 24, week 30 ] [ Designated as safety issue: No ]
    The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction

  • Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT) [ Time Frame: Baseline and 30 weeks ] [ Designated as safety issue: No ]
    The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.

  • Time to First Use of Rescue Therapy [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.

  • Incidence of Rescue Therapy During the First 30 Weeks of Treatment [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.


Enrollment: 936
Study Start Date: August 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
Drug: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Active Comparator: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
Drug: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Active Comparator: Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
Drug: Pioglitazone 45 mg
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Active Comparator: Linagliptin 5mg
Linagliptin 5mg Tablets once daily
Drug: Linagliptin 5mg
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Experimental: Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Drug: Linagliptin 5mg / Pioglitazone 15 mg FDC
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Experimental: Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Drug: Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Experimental: Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Drug: Linagliptin 5mg / Pioglitazone 45 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
  3. Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
  4. BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
  5. Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
  2. Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
  3. Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
  4. Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
  5. Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
  6. Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)
  7. Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :

    • Diagnose of heart failure or history of heart failure
    • Haemodialysis patients, due to limited experience with pioglitazone
  8. Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
  9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
  11. Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
  12. Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures
  15. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.

    A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner

  16. Symptomatic gallbladder disease in the last six months
  17. Medical history of pancreatitis.
  18. Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
  19. Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183013

  Hide Study Locations
Locations
United States, Alabama
1264.3.01026 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1264.3.01021 Boehringer Ingelheim Investigational Site
Montgomery, Alabama, United States
1264.3.01020 Boehringer Ingelheim Investigational Site
Muscle Shoals, Alabama, United States
United States, Arizona
1264.3.01062 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1264.3.01064 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
United States, California
1264.3.01049 Boehringer Ingelheim Investigational Site
Carmichael, California, United States
1264.3.01078 Boehringer Ingelheim Investigational Site
Chino, California, United States
1264.3.01031 Boehringer Ingelheim Investigational Site
Concord, California, United States
1264.3.01037 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1264.3.01065 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1264.3.01006 Boehringer Ingelheim Investigational Site
Norwalk, California, United States
1264.3.01001 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California, United States
1264.3.01059 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1264.3.01023 Boehringer Ingelheim Investigational Site
Tarzana, California, United States
1264.3.01016 Boehringer Ingelheim Investigational Site
Tustin, California, United States
1264.3.01058 Boehringer Ingelheim Investigational Site
Valencia, California, United States
1264.3.01083 Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
United States, Colorado
1264.3.01027 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Connecticut
1264.3.01033 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
United States, Florida
1264.3.01035 Boehringer Ingelheim Investigational Site
Boca Raton, Florida, United States
1264.3.01015 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1264.3.01082 Boehringer Ingelheim Investigational Site
Hialeah, Florida, United States
1264.3.01036 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1264.3.01013 Boehringer Ingelheim Investigational Site
Longwood, Florida, United States
1264.3.01042 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1264.3.01038 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1264.3.01079 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1264.3.01019 Boehringer Ingelheim Investigational Site
Port Orange, Florida, United States
1264.3.01018 Boehringer Ingelheim Investigational Site
St. Cloud, Florida, United States
1264.3.01012 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1264.3.01009 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Georgia
1264.3.01008 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1264.3.01061 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1264.3.01055 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1264.3.01074 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia, United States
1264.3.01084 Boehringer Ingelheim Investigational Site
Cartersville, Georgia, United States
1264.3.01060 Boehringer Ingelheim Investigational Site
Perry, Georgia, United States
1264.3.01050 Boehringer Ingelheim Investigational Site
Savannah, Georgia, United States
United States, Illinois
1264.3.01077 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Indiana
1264.3.01052 Boehringer Ingelheim Investigational Site
Brownsburg, Indiana, United States
1264.3.01075 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1264.3.01076 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1264.3.01073 Boehringer Ingelheim Investigational Site
Franklin, Indiana, United States
United States, Kansas
1264.3.01002 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
1264.3.01007 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Kentucky
1264.3.01010 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
United States, Louisiana
1264.3.01028 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1264.3.01029 Boehringer Ingelheim Investigational Site
Sunset, Louisiana, United States
United States, Maryland
1264.3.01069 Boehringer Ingelheim Investigational Site
Hyattsville, Maryland, United States
United States, Michigan
1264.3.01066 Boehringer Ingelheim Investigational Site
Southfield, Michigan, United States
United States, Montana
1264.3.01057 Boehringer Ingelheim Investigational Site
Great Falls, Montana, United States
United States, North Carolina
1264.3.01045 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
1264.3.01044 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
United States, Ohio
1264.3.01022 Boehringer Ingelheim Investigational Site
Zanesville, Ohio, United States
United States, Oklahoma
1264.3.01032 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
1264.3.01051 Boehringer Ingelheim Investigational Site
Fleetwood, Pennsylvania, United States
1264.3.01025 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
United States, South Carolina
1264.3.01081 Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
1264.3.01003 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
United States, Tennessee
1264.3.01011 Boehringer Ingelheim Investigational Site
Kingsport, Tennessee, United States
United States, Texas
1264.3.01017 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas, United States
1264.3.01067 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1264.3.01070 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1264.3.01039 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1264.3.01041 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1264.3.01004 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1264.3.01047 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1264.3.01040 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1264.3.01048 Boehringer Ingelheim Investigational Site
Midland, Texas, United States
1264.3.01030 Boehringer Ingelheim Investigational Site
New Braunfels, Texas, United States
1264.3.01071 Boehringer Ingelheim Investigational Site
North Richland Hills, Texas, United States
1264.3.01085 Boehringer Ingelheim Investigational Site
Plano, Texas, United States
1264.3.01046 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
1264.3.01056 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
Estonia
1264.3.37207 Boehringer Ingelheim Investigational Site
Harju, Estonia
1264.3.37209 Boehringer Ingelheim Investigational Site
Pärnu, Estonia
1264.3.37203 Boehringer Ingelheim Investigational Site
Tallin, Estonia
1264.3.37204 Boehringer Ingelheim Investigational Site
Tallin, Estonia
1264.3.37205 Boehringer Ingelheim Investigational Site
Tallin, Estonia
1264.3.37201 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1264.3.37208 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1264.3.37202 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1264.3.37206 Boehringer Ingelheim Investigational Site
Tartu, Estonia
1264.3.37210 Boehringer Ingelheim Investigational Site
Viljandi County, Estonia
Germany
1264.3.49001 Boehringer Ingelheim Investigational Site
Bad Lauterberg / Harz, Germany
1264.3.49007 Boehringer Ingelheim Investigational Site
Dietzenbach, Germany
1264.3.49002 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1264.3.49009 Boehringer Ingelheim Investigational Site
Essen, Germany
1264.3.49003 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1264.3.49012 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
1264.3.49008 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1264.3.49005 Boehringer Ingelheim Investigational Site
Mainz, Germany
1264.3.49010 Boehringer Ingelheim Investigational Site
Offenbach, Germany
1264.3.49004 Boehringer Ingelheim Investigational Site
Stuhr, Germany
Latvia
1264.3.37113 Boehringer Ingelheim Investigational Site
Daugavpils, Latvia
1264.3.37112 Boehringer Ingelheim Investigational Site
Daugavpils, Latvia
1264.3.37105 Boehringer Ingelheim Investigational Site
Daugavpils, Latvia
1264.3.37110 Boehringer Ingelheim Investigational Site
Jelgava, Latvia
1264.3.37101 Boehringer Ingelheim Investigational Site
Liepaja, Latvia
1264.3.37106 Boehringer Ingelheim Investigational Site
Ogre, Latvia
1264.3.37104 Boehringer Ingelheim Investigational Site
Riga, Latvia
1264.3.37108 Boehringer Ingelheim Investigational Site
Riga, Latvia
1264.3.37109 Boehringer Ingelheim Investigational Site
Riga, Latvia
1264.3.37111 Boehringer Ingelheim Investigational Site
Riga, Latvia
1264.3.37107 Boehringer Ingelheim Investigational Site
Talsi, Latvia
1264.3.37102 Boehringer Ingelheim Investigational Site
Tukums, Latvia
1264.3.37103 Boehringer Ingelheim Investigational Site
Valmiera, Latvia
Spain
1264.3.34013 Boehringer Ingelheim Investigational Site
Badía del Vallès - Barcelona, Spain
1264.3.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1264.3.34008 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1264.3.34005 Boehringer Ingelheim Investigational Site
Borges del Camp- Tarragona, Spain
1264.3.34006 Boehringer Ingelheim Investigational Site
Canet de Mar - Barcelona, Spain
1264.3.34010 Boehringer Ingelheim Investigational Site
Centelles - Barcelona, Spain
1264.3.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, Spain
1264.3.34004 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat - Barcelona, Spain
1264.3.34002 Boehringer Ingelheim Investigational Site
Sant Adrià del Besós- Barcelona, Spain
1264.3.34007 Boehringer Ingelheim Investigational Site
Tarrega - Lleida, Spain
1264.3.34012 Boehringer Ingelheim Investigational Site
Valencia, Spain
1264.3.34011 Boehringer Ingelheim Investigational Site
Vic - Barcelona, Spain
United Kingdom
1264.3.44032 Boehringer Ingelheim Investigational Site
Annan, United Kingdom
1264.3.44028 Boehringer Ingelheim Investigational Site
Ash Vale, Aldershot, United Kingdom
1264.3.44029 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow, United Kingdom
1264.3.44008 Boehringer Ingelheim Investigational Site
Balham, United Kingdom
1264.3.44021 Boehringer Ingelheim Investigational Site
Bradford on Avon, United Kingdom
1264.3.44019 Boehringer Ingelheim Investigational Site
Burbage, United Kingdom
1264.3.44012 Boehringer Ingelheim Investigational Site
Chesterfield, United Kingdom
1264.3.44027 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable, United Kingdom
1264.3.44011 Boehringer Ingelheim Investigational Site
Chippenham, United Kingdom
1264.3.44033 Boehringer Ingelheim Investigational Site
Johnstone, United Kingdom
1264.3.44007 Boehringer Ingelheim Investigational Site
Midsomer Norton, United Kingdom
1264.3.44034 Boehringer Ingelheim Investigational Site
Paisley, United Kingdom
1264.3.44031 Boehringer Ingelheim Investigational Site
Warminster, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01183013     History of Changes
Other Study ID Numbers: 1264.3, 2008-008127-15
Study First Received: August 16, 2010
Results First Received: March 12, 2014
Last Updated: June 3, 2014
Health Authority: Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014