Official Title: “A Randomised, Double-Blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.”

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: BI 1356
• Drug: Placebo
• Drug: Pioglitazone

Primary Measures

• Change from baseline in HbA1c (HbA1c after 24 weeks of treatment).
  • Time Frame: 24 weeks
    

Secondary Measures

• Secondary endpoints are the change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. The occurrence of a treat to target response that is an HbA1c under treatment of < or = to 7%.
  • Time Frame: 24 weeks
    

Inclusion Criteria:

• 1. Signed and dated written Informed Consent (IC) by date of Visit 1a in accordance with GCP and local legislation
• 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:

• 1. Myocardial infarction, stroke or TIA within 6 months prior to IC
• 2. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), 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 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 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 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 BI 1356 and pioglitazone.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641043

Study ID Number: 1218.15

ClinicalTrials.gov Identifier: NCT00641043

Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna