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. - Efficacy vs. PBO as initial combination therapy with pioglitazone
- Conditions
- Patients with type 2 Diabetes Mellitus with insufficient glycaemic control.MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2007-002456-41-GR
- Lead Sponsor
- Boehringer-Ingelheim Ellas AE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 375
1. All patients must sign an informed consent consistent with ICH-GCP (International Conference on Harmonization – Good Clinical Practice) guidelines prior to participation in the trial (Obtain written informed consent for enrolment into the trial prior to making any changes in medication or performing any procedures necessary to meet entry criteria).
2. Patients with a diagnosis of type 2 diabetes mellitus prior to informed consent and treatment naïve or previously treated with any oral hypoglycaemic agent.
3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening)
For patients undergoing wash out of previous medication: HbA1c 7.0-9.0%.
For patients not undergoing wash out of previous medication: HbA1c 7.5-10.0%.
4. Glycosylated haemoglobin A1 (HbA1c) 7.5-10.0% at Visit 2 (Start of Run-in) .
5. Male and female patients aged ? 18 and < 80 years at Visit 1a (Screening).
6. Body Mass Index (BMI) ? 40 kg/m2 at Visit 1a (Screening).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent.
2. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) as determined at Visit 1a.
3. Known hypersensitivity or allergy to the investigational product or its excipients), hypersensitivity or allergy to hydrochloride of pioglitazone or its excipients (carmellose calcium, hyprolose, lactose monohydrate, magnesium stearate).
4. Treatment with injectable GLP-1 analogue/agonist within 3 months prior to Informed Consent.
5. Treatment with insulin within 3 months prior to informed consent.
6. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, riminibant) 3 months prior to informed consent.
7. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation.
8. Participation in another trial with an investigational drug within 2 months prior to informed consent.
9. Pre-menopausal women (last menstruation ? 1 year prior to signing informed consent) 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.
10. Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to informed consent.
11. Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at screening .
12. Heart failure NYHA class III-IV (Class III: patients with marked limitation of activity; they are comfortable only at rest; Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest) or history of heart failure prior to this study.
13. Diabetic ketoacidosis within 6 months prior to informed consent.
14. Hemodialysis patients, due to limited experience with TZDs.
15. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of BI 1356 and pioglitazone.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the 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. ;Secondary Objective: ;Primary end point(s): The primary endpoint for this study will be the change from baseline in HbA1c (HbA1c after 24 weeks of treatment).
- Secondary Outcome Measures
Name Time Method