Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone
NCT ID: NCT00641043
Last Updated: 2014-02-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
389 participants
INTERVENTIONAL
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
NCT00621140
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
NCT01183013
Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin/Pioglitazone Compared With Single Linagliptin and Pioglitazone Tablets Administered Together to Healthy Male and Female Subjects
NCT02183636
BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
NCT02183324
Japanese P III vs Voglibose and Placebo
NCT00654381
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BI 1356 (5 mg)
BI 1356 5mg in initial combination therapy with pioglitazone 30 mg
Linagliptin + pioglitazone (30 mg)
5 mg tablet + overcapsulated 30 mg tablet, once daily
Placebo matching BI 1356 5 mg
Placebo in initial combination therapy with pioglitazone 30 mg
placebo + pioglitazone (30 mg)
placebo + overcapsulated 30 mg tablet, once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo + pioglitazone (30 mg)
placebo + overcapsulated 30 mg tablet, once daily
Linagliptin + pioglitazone (30 mg)
5 mg tablet + overcapsulated 30 mg tablet, once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with a diagnosis of type 2 diabetes mellitus and treatment naive or previously treated with any oral hypoglycaemic agent; antidiabetic therapy has to be unchanged for ten weeks prior to informed consent.
3. Glycosylated haemoglobin A1 (HbA1c) 7.5-11% at Visit 2 (Start of Run-in).
4. Male and female patients aged \> or = 18 and \< or = to 80 years at Visit 1a (Screening).
5. Body Mass Index (BMI) \< or = 40 kg/m2 at Visit 1a (Screening)
6. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Exclusion Criteria
2. Impaired hepatic function, defined by serum levels of either Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) determined at Visit 1a.
3. Known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
4. Treatment with Glucagon-like peptide-1 (GLP-1) analogue / agonist within 3 months prior to IC.
5. Treatment with insulin within 3 months prior to IC
6. Treatment with anti-obesity drugs 3 months prior to IC.
7. Alcohol abuse within the 3 months prior to IC that would interfere with trial participation or drug abuse.
8. Participation in another trial with an investigational drug within 2 months prior to IC.
9. Fasting blood glucose \> 240 mg/dl (=13.3 mmol/L) at screening (Visit 1).
10. Pre-menopausal women (last menstruation \< or =1 year prior to signing IC) who:
* are nursing or pregnant,
* or are of child-bearing potential and are not practicing an acceptable 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. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
11. Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to IC
12. Heart failure New York Heart Asociation (NYHA) class I-IV, or history of heart failure.
13. Diabetic ketoacidosis within 6 months prior to IC.
14. Hemodialyzed patients due to limited experience with Thiazolidinediones (TZDs)
15. Any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of BI1356 and pioglitazone.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Boehringer Ingelheim
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1218.15.43004 Boehringer Ingelheim Investigational Site
Feldkirch, , Austria
1218.15.43001 Boehringer Ingelheim Investigational Site
Graz, , Austria
1218.15.43003 Boehringer Ingelheim Investigational Site
Vienna, , Austria
1218.15.43005 Boehringer Ingelheim Investigational Site
Vienna, , Austria
1218.15.30004 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.15.30007 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.15.30017 Boehringer Ingelheim Investigational Site
Ioannina, , Greece
1218.15.30002 Boehringer Ingelheim Investigational Site
Melissia-Athens, , Greece
1218.15.30003 Boehringer Ingelheim Investigational Site
Nikaia, , Greece
1218.15.30006 Boehringer Ingelheim Investigational Site
Thessaloniki, , Greece
1218.15.30014 Boehringer Ingelheim Investigational Site
Thessaloniki, , Greece
1218.15.30016 Boehringer Ingelheim Investigational Site
Thessaloniki, , Greece
1218.15.36003 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1218.15.36004 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1218.15.36006 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1218.15.36008 Boehringer Ingelheim Investigational Site
Debrecen, , Hungary
1218.15.36005 Boehringer Ingelheim Investigational Site
Győr, , Hungary
1218.15.36002 Boehringer Ingelheim Investigational Site
Szombathely, , Hungary
1218.15.81001 Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo, , Japan
1218.15.81005 Boehringer Ingelheim Investigational Site
Koganei, Tokyo, , Japan
1218.15.81002 Boehringer Ingelheim Investigational Site
Osaka, Osaka, , Japan
1218.15.81004 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, , Japan
1218.15.81003 Boehringer Ingelheim Investigational Site
Suita, Osaka,, , Japan
1218.15.35007 Boehringer Ingelheim Investigational Site
Aveiro, , Portugal
1218.15.35001 Boehringer Ingelheim Investigational Site
Lisbon, , Portugal
1218.15.40504 Boehringer Ingelheim Investigational Site
Alba Iulia, , Romania
1218.15.40501 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1218.15.40502 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1218.15.40503 Boehringer Ingelheim Investigational Site
Sibiu, , Romania
1218.15.40505 Boehringer Ingelheim Investigational Site
Târgu Mureş, , Romania
1218.15.34002 Boehringer Ingelheim Investigational Site
Badalona, , Spain
1218.15.34011 Boehringer Ingelheim Investigational Site
Badia Del Vallés, , Spain
1218.15.34001 Boehringer Ingelheim Investigational Site
Bercelona, , Spain
1218.15.34012 Boehringer Ingelheim Investigational Site
Borges Del Camp, , Spain
1218.15.34013 Boehringer Ingelheim Investigational Site
Centelles, , Spain
1218.15.34007 Boehringer Ingelheim Investigational Site
Granada, , Spain
1218.15.34008 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona), , Spain
1218.15.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona), , Spain
1218.15.34004 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1218.15.34006 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1218.15.34010 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós (Barcelona), , Spain
1218.15.34005 Boehringer Ingelheim Investigational Site
Seville, , Spain
1218.15.34014 Boehringer Ingelheim Investigational Site
Vic (Barcelona), , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-002456-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1218.15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.