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

• Conditions: Type 2 diabete mellitus; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000383-10-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-29
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2746

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-naive (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) 4. Age >= 18 years 5. Body Mass Index (BMI) <=45 kg/m2 at Visit 1 (screening) 6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
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 2060
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 686

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) Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent 4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in period 5. Impaired renal function, defined as eGFR <60 ml/min (MDRD formula) as determined during screening and/or run-in period 6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Blood dyscrasias or any disorders causing hemolysis or unstable (shortened half-life) red blood cell (e.g. malaria, babesiosis, hemolytic anemia) 9. Contraindications to metformin according to the local label 10. Treatment with anti-obesity drugs within 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight 11. Current treatment with systemic steroids (other than inhalative steriods) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM 12. Pre-menopausal women (last menstruation <=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 trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, complete sexual abstinence (if acceptable by local health authorities), double barrier method and vasectomized partner 13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to trial procedures or trial drug intake, in the judgment of the investigator 14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participation in the follow-up period of another trial (partipation in observational studies is permitted) 15. Any other clinical condition that, in the opinion of the investigator, would jeopardize patient's safety while participating in this clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified