A clinical Trial to compare the effects and safety of different combinations of the trial drug and metformin over 24 weeks in drug naÃ¯ve or previously treated (after with holding the treatment for 4 weeks) type 2 diabetic patients with poor control of blood sugar levels.

A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naÃ¯ve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000125

Enrollment

792

Registered

2009-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: BI 1356 2.5 mg + metformin 500 mg,: BI 1356 2.5 mg + metformin 500 mg, Intervention2: BI 1356 2.5 mg + metformin 1000 mg: BI 1356 2.5 mg + metformin 1000 mg Control Intervention1: Metfo

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment drug naÃ¯ve patients or previously treated patients with not more than one oral antidiabetic drug. Antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent 2. Diagnosis of type 2 diabetes prior to informed consent 3. Glycosylated haemoglobin A1c (HbA1c) at Visit 1a (Screening): For patients undergoing wash-out (pre-treated patients): HbA1c ≥ 7.0 to ≤ 10.5 % For naÃ¯ve patients not undergoing wash-out: HbA1c ≥ 7.5 to 4. Glycosylated haemoglobin A1c (HbA1c) ≥ 7.5 to (Start of Run-in) 5.Patients with very poor glycaemic control [HbA1c ≥ 11 %, determined by examination at Visit 1a (naÃ¯ve patients) or at Visit 2 (naÃ¯ve and pre-treated patients)] will be eligible to participate in an additional open-label study arm 6. Age ≥ 18 and ≤ 80 years at Visit 1a (Screening) 7. BMI (Body Mass Index) ≤ 40 kg/m2 at Visit 1a (Screening) 8. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation Exclusion Criteria: A history of coronary heart disease or stroke, serum creatinine >1.5 mg/dl, albuminuria >40 μg/min, and use of lipid-lowering drugs, aspirin, or other antihypertensive agents.

Exclusion criteria

Exclusion criteria: 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 (AP) above 3 x upper limit of normal (ULN) as determined at Visit 1a 3. Known hypersensitivity or allergy to BI 1356 or its excipients or metformin or placebo 4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent 5. Treatment with a GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent 6. Treatment with insulin within 3 months prior to informed consent 7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent 8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse 9. Participation in another trial with an investigational drug within 2 months prior to informed consent 10. Pre-menopausal women (last menstruation &#8804; 1 year prior to 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. 11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. However, inhaled use of steroids (e.g. for asthma/COPD) is no exclusion criterion, as this does not cause systemic steroid action. 12. Renal failure or renal impairment at Visit 1a (screening) with an eGFR < 60 ml/min 13. Gastric bypass 14. Dehydration by clinical judgement of the investigator 15. Unstable or acute congestive heart failure 16. Acute or chronic metabolic acidosis (present in patient history) 17. Hereditary galactose intolerance

Design outcomes

Secondary

Measure	Time frame
The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of less than or equal to 7.0 % after 24 weeks of treatmentTimepoint: 24 weeks	—

Primary

Measure	Time frame
HbA1cTimepoint: The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment	—

Countries

Brazil, Canada, Croatia, Estonia, France, Germany, India, Lithuania, Mexico, Netherlands, Romania, Russian Federation, South Africa, Sweden, Ukraine

Contacts

Public ContactSuchela Srivatsa

IQVIA RDS (India) Private Limited

shoibal.mukherjee@quintiles.com91-7838652395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026