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

Conditions: Type 2 Diabetes Mellitus
MedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-000383-10-HU

Lead Sponsor: Boehringer Ingelheim RCV GmBH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1300

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

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

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 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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change from baseline in fasting plasma glucose<br>2. Change from baseline in body weight ;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment