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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

NCT ID: NCT01183013

Last Updated: 2014-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Pioglitazone 15 mg

Pioglitazone Capsules 15 mg once daily

Group Type ACTIVE_COMPARATOR

Pioglitazone 15 mg

Intervention Type DRUG

Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks

Pioglitazone 30 mg

Pioglitazone Capsules 30 mg once daily

Group Type ACTIVE_COMPARATOR

Pioglitazone 30 mg

Intervention Type DRUG

Pioglitazone Capsules 30 mg once daily for up to 84 weeks

Pioglitazone 45 mg

Pioglitazone Capsules 45 mg once daily

Group Type ACTIVE_COMPARATOR

Pioglitazone 45 mg

Intervention Type DRUG

Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks

Linagliptin 5mg

Linagliptin 5mg Tablets once daily

Group Type ACTIVE_COMPARATOR

Linagliptin 5mg

Intervention Type DRUG

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

Linagliptin 5mg / Pioglitazone 15 mg

Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily

Group Type EXPERIMENTAL

Linagliptin 5mg / Pioglitazone 15 mg FDC

Intervention Type DRUG

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

Linagliptin 5mg / Pioglitazone 30 mg

Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily

Group Type EXPERIMENTAL

Linagliptin 5mg / Pioglitazone 30 mg FDC

Intervention Type DRUG

Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks

Linagliptin 5mg / Pioglitazone 45 mg

Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily

Group Type EXPERIMENTAL

Linagliptin 5mg / Pioglitazone 45 mg FDC

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Pioglitazone 30 mg

Pioglitazone Capsules 30 mg once daily for up to 84 weeks

Intervention Type 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

Intervention Type DRUG

Linagliptin 5mg / Pioglitazone 30 mg FDC

Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1264.3.01026 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1264.3.01021 Boehringer Ingelheim Investigational Site

Montgomery, Alabama, United States

Site Status

1264.3.01020 Boehringer Ingelheim Investigational Site

Muscle Shoals, Alabama, United States

Site Status

1264.3.01062 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

Site Status

1264.3.01064 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Site Status

1264.3.01049 Boehringer Ingelheim Investigational Site

Carmichael, California, United States

Site Status

1264.3.01078 Boehringer Ingelheim Investigational Site

Chino, California, United States

Site Status

1264.3.01031 Boehringer Ingelheim Investigational Site

Concord, California, United States

Site Status

1264.3.01037 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Site Status

1264.3.01065 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1264.3.01006 Boehringer Ingelheim Investigational Site

Norwalk, California, United States

Site Status

1264.3.01001 Boehringer Ingelheim Investigational Site

Rancho Cucamonga, California, United States

Site Status

1264.3.01059 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1264.3.01023 Boehringer Ingelheim Investigational Site

Tarzana, California, United States

Site Status

1264.3.01016 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Site Status

1264.3.01058 Boehringer Ingelheim Investigational Site

Valencia, California, United States

Site Status

1264.3.01083 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Site Status

1264.3.01027 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1264.3.01033 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Site Status

1264.3.01035 Boehringer Ingelheim Investigational Site

Boca Raton, Florida, United States

Site Status

1264.3.01015 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1264.3.01082 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Site Status

1264.3.01036 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

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1264.3.01013 Boehringer Ingelheim Investigational Site

Longwood, Florida, United States

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1264.3.01038 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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1264.3.01042 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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1264.3.01079 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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1264.3.01019 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

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1264.3.01018 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

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1264.3.01009 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1264.3.01012 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1264.3.01008 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1264.3.01055 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1264.3.01061 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1264.3.01074 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

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1264.3.01084 Boehringer Ingelheim Investigational Site

Cartersville, Georgia, United States

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1264.3.01060 Boehringer Ingelheim Investigational Site

Perry, Georgia, United States

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1264.3.01050 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

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1264.3.01077 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

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1264.3.01052 Boehringer Ingelheim Investigational Site

Brownsburg, Indiana, United States

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1264.3.01075 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

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1264.3.01076 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

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1264.3.01073 Boehringer Ingelheim Investigational Site

Franklin, Indiana, United States

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1264.3.01002 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

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1264.3.01007 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

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1264.3.01010 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

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1264.3.01028 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1264.3.01029 Boehringer Ingelheim Investigational Site

Sunset, Louisiana, United States

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1264.3.01069 Boehringer Ingelheim Investigational Site

Hyattsville, Maryland, United States

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1264.3.01066 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

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1264.3.01057 Boehringer Ingelheim Investigational Site

Great Falls, Montana, United States

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1264.3.01045 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

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1264.3.01044 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

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1264.3.01022 Boehringer Ingelheim Investigational Site

Zanesville, Ohio, United States

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1264.3.01032 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1264.3.01051 Boehringer Ingelheim Investigational Site

Fleetwood, Pennsylvania, United States

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1264.3.01025 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

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1264.3.01081 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

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1264.3.01003 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

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1264.3.01011 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

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1264.3.01017 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

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1264.3.01067 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1264.3.01004 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1264.3.01039 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1264.3.01041 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1264.3.01047 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1264.3.01070 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1264.3.01040 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

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1264.3.01048 Boehringer Ingelheim Investigational Site

Midland, Texas, United States

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1264.3.01030 Boehringer Ingelheim Investigational Site

New Braunfels, Texas, United States

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1264.3.01071 Boehringer Ingelheim Investigational Site

North Richland Hills, Texas, United States

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1264.3.01085 Boehringer Ingelheim Investigational Site

Plano, Texas, United States

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1264.3.01046 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1264.3.01056 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

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1264.3.37207 Boehringer Ingelheim Investigational Site

Harju, , Estonia

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1264.3.37209 Boehringer Ingelheim Investigational Site

Pärnu, , Estonia

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1264.3.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1264.3.37202 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1264.3.37203 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1264.3.37204 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1264.3.37205 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1264.3.37208 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1264.3.37206 Boehringer Ingelheim Investigational Site

Tartu, , Estonia

Site Status

1264.3.37210 Boehringer Ingelheim Investigational Site

Viljandi County, , Estonia

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1264.3.49001 Boehringer Ingelheim Investigational Site

Bad Lauterberg / Harz, , Germany

Site Status

1264.3.49007 Boehringer Ingelheim Investigational Site

Dietzenbach, , Germany

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1264.3.49002 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1264.3.49009 Boehringer Ingelheim Investigational Site

Essen, , Germany

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1264.3.49003 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1264.3.49012 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

1264.3.49008 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1264.3.49005 Boehringer Ingelheim Investigational Site

Mainz, , Germany

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1264.3.49010 Boehringer Ingelheim Investigational Site

Offenbach, , Germany

Site Status

1264.3.49004 Boehringer Ingelheim Investigational Site

Stuhr, , Germany

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1264.3.37105 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

Site Status

1264.3.37112 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

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1264.3.37113 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

Site Status

1264.3.37110 Boehringer Ingelheim Investigational Site

Jelgava, , Latvia

Site Status

1264.3.37101 Boehringer Ingelheim Investigational Site

Liepāja, , Latvia

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1264.3.37106 Boehringer Ingelheim Investigational Site

Ogre, , Latvia

Site Status

1264.3.37104 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1264.3.37108 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1264.3.37109 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1264.3.37111 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1264.3.37107 Boehringer Ingelheim Investigational Site

Talsi, , Latvia

Site Status

1264.3.37102 Boehringer Ingelheim Investigational Site

Tukums, , Latvia

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1264.3.37103 Boehringer Ingelheim Investigational Site

Valmiera, , Latvia

Site Status

1264.3.34013 Boehringer Ingelheim Investigational Site

Badía Del Vallès - Barcelona, , Spain

Site Status

1264.3.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1264.3.34008 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1264.3.34005 Boehringer Ingelheim Investigational Site

Borges Del Camp- Tarragona, , Spain

Site Status

1264.3.34006 Boehringer Ingelheim Investigational Site

Canet de Mar - Barcelona, , Spain

Site Status

1264.3.34010 Boehringer Ingelheim Investigational Site

Centelles - Barcelona, , Spain

Site Status

1264.3.34009 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1264.3.34004 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat - Barcelona, , Spain

Site Status

1264.3.34002 Boehringer Ingelheim Investigational Site

Sant Adrià Del Besós- Barcelona, , Spain

Site Status

1264.3.34007 Boehringer Ingelheim Investigational Site

Tarrega - Lleida, , Spain

Site Status

1264.3.34012 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1264.3.34011 Boehringer Ingelheim Investigational Site

Vic - Barcelona, , Spain

Site Status

1264.3.44032 Boehringer Ingelheim Investigational Site

Annan, , United Kingdom

Site Status

1264.3.44028 Boehringer Ingelheim Investigational Site

Ash Vale, Aldershot, , United Kingdom

Site Status

1264.3.44029 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, , United Kingdom

Site Status

1264.3.44008 Boehringer Ingelheim Investigational Site

Balham, , United Kingdom

Site Status

1264.3.44021 Boehringer Ingelheim Investigational Site

Bradford-on-Avon, , United Kingdom

Site Status

1264.3.44019 Boehringer Ingelheim Investigational Site

Burbage, , United Kingdom

Site Status

1264.3.44012 Boehringer Ingelheim Investigational Site

Chesterfield, , United Kingdom

Site Status

1264.3.44027 Boehringer Ingelheim Investigational Site

Chestfield, Whitstable, , United Kingdom

Site Status

1264.3.44011 Boehringer Ingelheim Investigational Site

Chippenham, , United Kingdom

Site Status

1264.3.44033 Boehringer Ingelheim Investigational Site

Johnstone, , United Kingdom

Site Status

1264.3.44007 Boehringer Ingelheim Investigational Site

Midsomer Norton, , United Kingdom

Site Status

1264.3.44034 Boehringer Ingelheim Investigational Site

Paisley, , United Kingdom

Site Status

1264.3.44031 Boehringer Ingelheim Investigational Site

Warminster, , United Kingdom

Site Status

Countries

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United States Estonia Germany Latvia Spain United Kingdom

Other Identifiers

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2008-008127-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1264.3

Identifier Type: -

Identifier Source: org_study_id

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A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
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Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
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Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)
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Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
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Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
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