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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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: 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)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

Summary

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.

Clinical Details

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

Primary outcome: Change From Baseline in HbA1c After 30 Weeks of Treatment.

Secondary outcome:

Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment

Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment

Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)

HbA1c Change From Baseline by Visit Over Time

Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment

Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time

Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)

Time to First Use of Rescue Therapy

Incidence of Rescue Therapy During the First 30 Weeks of Treatment

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

1264.3.37207 Boehringer Ingelheim Investigational Site, Harju, Estonia

1264.3.37209 Boehringer Ingelheim Investigational Site, Pärnu, Estonia

1264.3.37201 Boehringer Ingelheim Investigational Site, Tallinn, Estonia

1264.3.37202 Boehringer Ingelheim Investigational Site, Tallinn, Estonia

1264.3.37208 Boehringer Ingelheim Investigational Site, Tallinn, 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

1264.3.37206 Boehringer Ingelheim Investigational Site, Tartu, Estonia

1264.3.37210 Boehringer Ingelheim Investigational Site, Viljandi County, Estonia

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

1264.3.37105 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia

1264.3.37112 Boehringer Ingelheim Investigational Site, Daugavpils, Latvia

1264.3.37113 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

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

1264.3.34004 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat - Barcelona, Spain

1264.3.34009 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, 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

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

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

1264.3.01062 Boehringer Ingelheim Investigational Site, Chandler, Arizona, United States

1264.3.01064 Boehringer Ingelheim Investigational Site, Mesa, Arizona, United States

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

1264.3.01027 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States

1264.3.01033 Boehringer Ingelheim Investigational Site, Norwalk, Connecticut, United States

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

1264.3.01038 Boehringer Ingelheim Investigational Site, Miami, Florida, United States

1264.3.01042 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

1264.3.01009 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States

1264.3.01012 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States

1264.3.01008 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

1264.3.01055 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

1264.3.01061 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

1264.3.01077 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States

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

1264.3.01002 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States

1264.3.01007 Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States

1264.3.01010 Boehringer Ingelheim Investigational Site, Lexington, Kentucky, United States

1264.3.01028 Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States

1264.3.01029 Boehringer Ingelheim Investigational Site, Sunset, Louisiana, United States

1264.3.01069 Boehringer Ingelheim Investigational Site, Hyattsville, Maryland, United States

1264.3.01066 Boehringer Ingelheim Investigational Site, Southfield, Michigan, United States

1264.3.01057 Boehringer Ingelheim Investigational Site, Great Falls, Montana, United States

1264.3.01045 Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States

1264.3.01044 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States

1264.3.01022 Boehringer Ingelheim Investigational Site, Zanesville, Ohio, United States

1264.3.01032 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

1264.3.01051 Boehringer Ingelheim Investigational Site, Fleetwood, Pennsylvania, United States

1264.3.01025 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States

1264.3.01081 Boehringer Ingelheim Investigational Site, Columbia, South Carolina, United States

1264.3.01003 Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States

1264.3.01011 Boehringer Ingelheim Investigational Site, Kingsport, Tennessee, United States

1264.3.01017 Boehringer Ingelheim Investigational Site, Corpus Christi, Texas, United States

1264.3.01067 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

1264.3.01004 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

1264.3.01047 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1264.3.01070 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

1264.3.01056 Boehringer Ingelheim Investigational Site, Norfolk, Virginia, United States

Additional Information

Starting date: August 2010
Last updated: October 9, 2014

Page last updated: August 23, 2015

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