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
- NCT01183013
- PHASE3
- INTERVENTIONAL
Last updated: 2014-10-20
Purpose of Trial
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.
This study is for people with
Diabetes Mellitus, Type 2
Interventions being studied
Pioglitazone 15 mg
Pioglitazone 45 mg
Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 45 mg FDC
Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg
Linagliptin 5mg / Pioglitazone 15 mg FDC
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.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
74 Locations
Birmingham
1264.3.01026 Boehringer Ingelheim Investigational Site
Alabama, United States
Montgomery
1264.3.01021 Boehringer Ingelheim Investigational Site
Alabama, United States
Muscle Shoals
1264.3.01020 Boehringer Ingelheim Investigational Site
Alabama, United States
Chandler
1264.3.01062 Boehringer Ingelheim Investigational Site
Arizona, United States
Mesa
1264.3.01064 Boehringer Ingelheim Investigational Site
Arizona, United States
Carmichael
1264.3.01049 Boehringer Ingelheim Investigational Site
California, United States
Chino
1264.3.01078 Boehringer Ingelheim Investigational Site
California, United States
Concord
1264.3.01031 Boehringer Ingelheim Investigational Site
California, United States
Lakewood
1264.3.01037 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1264.3.01065 Boehringer Ingelheim Investigational Site
California, United States
Norwalk
1264.3.01006 Boehringer Ingelheim Investigational Site
California, United States
Rancho Cucamonga
1264.3.01001 Boehringer Ingelheim Investigational Site
California, United States
San Diego
1264.3.01059 Boehringer Ingelheim Investigational Site
California, United States
Tarzana
1264.3.01023 Boehringer Ingelheim Investigational Site
California, United States
Tustin
1264.3.01016 Boehringer Ingelheim Investigational Site
California, United States
Valencia
1264.3.01058 Boehringer Ingelheim Investigational Site
California, United States
Westlake Village
1264.3.01083 Boehringer Ingelheim Investigational Site
California, United States
Denver
1264.3.01027 Boehringer Ingelheim Investigational Site
Colorado, United States
Norwalk
1264.3.01033 Boehringer Ingelheim Investigational Site
Connecticut, United States
Boca Raton
1264.3.01035 Boehringer Ingelheim Investigational Site
Florida, United States
Clearwater
1264.3.01015 Boehringer Ingelheim Investigational Site
Florida, United States
Hialeah
1264.3.01082 Boehringer Ingelheim Investigational Site
Florida, United States
Jacksonville
1264.3.01036 Boehringer Ingelheim Investigational Site
Florida, United States
Longwood
1264.3.01013 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
1264.3.01038 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
1264.3.01042 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
1264.3.01079 Boehringer Ingelheim Investigational Site
Florida, United States
Port Orange
1264.3.01019 Boehringer Ingelheim Investigational Site
Florida, United States
St. Cloud
1264.3.01018 Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
1264.3.01009 Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
1264.3.01012 Boehringer Ingelheim Investigational Site
Florida, United States
Atlanta
1264.3.01008 Boehringer Ingelheim Investigational Site
Georgia, United States
Atlanta
1264.3.01055 Boehringer Ingelheim Investigational Site
Georgia, United States
Atlanta
1264.3.01061 Boehringer Ingelheim Investigational Site
Georgia, United States
Blue Ridge
1264.3.01074 Boehringer Ingelheim Investigational Site
Georgia, United States
Cartersville
1264.3.01084 Boehringer Ingelheim Investigational Site
Georgia, United States
Perry
1264.3.01060 Boehringer Ingelheim Investigational Site
Georgia, United States
Savannah
1264.3.01050 Boehringer Ingelheim Investigational Site
Georgia, United States
Chicago
1264.3.01077 Boehringer Ingelheim Investigational Site
Illinois, United States
Brownsburg
1264.3.01052 Boehringer Ingelheim Investigational Site
Indiana, United States
Evansville
1264.3.01075 Boehringer Ingelheim Investigational Site
Indiana, United States
Evansville
1264.3.01076 Boehringer Ingelheim Investigational Site
Indiana, United States
Franklin
1264.3.01073 Boehringer Ingelheim Investigational Site
Indiana, United States
Wichita
1264.3.01002 Boehringer Ingelheim Investigational Site
Kansas, United States
Wichita
1264.3.01007 Boehringer Ingelheim Investigational Site
Kansas, United States
Lexington
1264.3.01010 Boehringer Ingelheim Investigational Site
Kentucky, United States
New Orleans
1264.3.01028 Boehringer Ingelheim Investigational Site
Louisiana, United States
Sunset
1264.3.01029 Boehringer Ingelheim Investigational Site
Louisiana, United States
Hyattsville
1264.3.01069 Boehringer Ingelheim Investigational Site
Maryland, United States
Southfield
1264.3.01066 Boehringer Ingelheim Investigational Site
Michigan, United States
Great Falls
1264.3.01057 Boehringer Ingelheim Investigational Site
Montana, United States
Burlington
1264.3.01045 Boehringer Ingelheim Investigational Site
North Carolina, United States
Charlotte
1264.3.01044 Boehringer Ingelheim Investigational Site
North Carolina, United States
Zanesville
1264.3.01022 Boehringer Ingelheim Investigational Site
Ohio, United States
Oklahoma City
1264.3.01032 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Fleetwood
1264.3.01051 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Pittsburgh
1264.3.01025 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Columbia
1264.3.01081 Boehringer Ingelheim Investigational Site
South Carolina, United States
Greer
1264.3.01003 Boehringer Ingelheim Investigational Site
South Carolina, United States
Kingsport
1264.3.01011 Boehringer Ingelheim Investigational Site
Tennessee, United States
Corpus Christi
1264.3.01017 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1264.3.01067 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1264.3.01004 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1264.3.01039 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1264.3.01041 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1264.3.01047 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1264.3.01070 Boehringer Ingelheim Investigational Site
Texas, United States
Killeen
1264.3.01040 Boehringer Ingelheim Investigational Site
Texas, United States
Midland
1264.3.01048 Boehringer Ingelheim Investigational Site
Texas, United States
New Braunfels
1264.3.01030 Boehringer Ingelheim Investigational Site
Texas, United States
North Richland Hills
1264.3.01071 Boehringer Ingelheim Investigational Site
Texas, United States
Plano
1264.3.01085 Boehringer Ingelheim Investigational Site
Texas, United States
San Antonio
1264.3.01046 Boehringer Ingelheim Investigational Site
Texas, United States
Norfolk
1264.3.01056 Boehringer Ingelheim Investigational Site
Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov