Safety and efficacy study of empagliflozin and metformin for 24 weeks in treatment naive patients with type 2 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1344

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
3. HbA1c = 7.5% and = 10% (=58.5 mmol/mol and =85.8 mmol/mol) at Visit 1 (screening)
4. Age =18
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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1075
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 269

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 laboratory measurement (not on the same day)
2. Any antidiabetic drug within 12 weeks prior to randomization
3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack (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 estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault 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. Known blood dyscrasias or any disorders causing hemolysis or unstable 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 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 study 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 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 study procedures or study drug intake
14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial
15. Any other clinical condition that would jeopardize patient’s safety while participating in this clinical trial in the opinion of the investigator

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 and safety of empagliflozin 5 mg bid + metformin 500 mg bid, empagliflozin 5 mg bid + metformin 1000 mg bid, empagliflozin 12.5 mg bid + metformin 500 mg bid and empagliflozin 12.5 mg bid + metformin 1000 mg bid compared with the individual components of empagliflozin (10 mg or 25 mg qd) or metformin (500 mg or 1000 mg bid) in patients with T2DM treated with diet and exercise with insufficient glycemic control. ;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment.;Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

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

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