A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008494-59-NL

Enrollment

700

Registered

2009-04-08

Start date

2009-06-12

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Type 2 diabetic patients MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Product Name: linagliptin Product Code: BI 1356 BS Pharmaceutical Form: Film-coated tablet INN or Proposed INN: linagliptin CAS Number: 668270-12-0 Current Sponsor code: BI 1356 BS Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed and dated written informed consent 2. Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7) 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

Exclusion criteria

Exclusion criteria: 1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46 2. Pre-menopausal women (last menstruation less or equal than 1 year prior signing informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control 3. Alcohol abuse within 3 months prior to informed consent 4. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the current study is to investigate the safety and efficacy of linagliptin 2.5 mg plus metformin either 500 mg or 1000 mg, twice daily in comparison to metformin 1000 mg monotherapy twice daily given for 54 weeks.;Secondary Objective: N/A;Primary end point(s): Safety and tolerability wil be assessed in a drscriptive analysis based on: Incidence and intensity of AEs, withdrawal due to AEs, clinically relevant new or worsening findings in physical examination, changes from baseline in vital signs and clinical laboratory assesments, clinically relevant new or worsening findings in 12-lead ECG	—

Measure

Time frame

Main Objective: The objective of the current study is to investigate the safety and efficacy of linagliptin 2.5 mg plus metformin either 500 mg or 1000 mg, twice daily in comparison to metformin 1000 mg monotherapy twice daily given for 54 weeks.;Secondary Objective: N/A;Primary end point(s): Safety and tolerability wil be assessed in a drscriptive analysis based on: Incidence and intensity of AEs, withdrawal due to AEs, clinically relevant new or worsening findings in physical examination, changes from baseline in vital signs and clinical laboratory assesments, clinically relevant new or worsening findings in 12-lead ECG

—

Countries

Estonia, France, Germany, Lithuania, Netherlands, Sweden

Outcome results

None listed

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