Efficacy and safety of BI 10773/BI 1356 Fixed Dose Combination iin treatment naïve and metformin treated type 2 diabetes patients

A phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of once daily oral administration of linagliptin 5 mg/BI 10773 25 mg and linagliptin 5 mg/BI 10773 10 mg Fixed Dose Combination tablets compared with the individual components linagliptin 5 mg, BI 10773 25 mg, and BI 10773 10 mg) for 52 weeks in treatment naïve and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000383-10-EE

Enrollment

1300

Registered

2011-06-16

Start date

2011-07-06

Completion date

Unknown

Last updated

2013-11-26

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

Conditions

Type 2 Diabetes Mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: linagliptin + BI 10773 Product Code: linagliptin + BI 10773 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: linagliptin Current Sponsor code: BI 1356 BS Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. 3. HbA1c = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 975 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 325

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). 2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2) 3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to investigate the efficacy, safety and tolerability of BI 10773 25 mg/linagliptin 5 mg FDC qd and of BI 10773 10 mg/ linagliptin 5 mg FDC qd compared to the individual components (BI 10773 25 mg, BI 10773 10 mg, and linagliptin 5 mg) given for 52 weeks in treatment naïve and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control. ;Secondary Objective: Not applicable;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment	—

Measure

Time frame

Main Objective: The objective of the study is to investigate the efficacy, safety and tolerability of BI 10773 25 mg/linagliptin 5 mg FDC qd and of BI 10773 10 mg/ linagliptin 5 mg FDC qd compared to the individual components (BI 10773 25 mg, BI 10773 10 mg, and linagliptin 5 mg) given for 52 weeks in treatment naïve and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control. ;Secondary Objective: Not applicable;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline in fasting plasma glucose 2. Change from baseline in body weight ;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, Estonia, Hungary, India, Italy, Korea, Democratic People's Republic of, Lebanon, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com0018002430127

Outcome results

None listed

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