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
Conditions
Interventions
Product Name: BI 10773
Product Code: BI 10773
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
Current Sponsor code: BI 10773
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent and a eGFR of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycaemia 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. Impaired renal function, defined as eGFR<15 ml/min using the MDRD equation.as determined during screening and/or the run-in phase 3. Renal impairment requiring any form of chronic dialysis. 4. Requiring acute dialysis within three months prior to informed consent. 5. Renal transplant recipient. 6. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or Transient Ischemic Attack (TIA) within three months prior to informed consent. 7. Indication of liver disease, defined by serum levels of either Alanine transaminase (ALT) (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or the run-in phase. 8. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption. 9. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last five years. 10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, haemolytic anemia). 11. Contraindications to pre-existing background antidiabetic therapy according to the local label. 12. Treatment with anti-obesity drugs three 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. 13. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM. 14. 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 practising 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, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner. 15.Alcohol or drug abuse within the three 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. 16.Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial; or participating in another trial (involving an investigational drug and/or follow-up) after discontinuing medication in this trial. 17.Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg and 25 mg/ once daily) compared to placebo given for 52 weeks as add-on pre-existing antidiabetic therapy in patients with T2DM with insufficient glycaemic control and renal impairment. The study is designed to show superiority of BI 10773 over placebo.;Secondary Objective: •HbA1c: Change from baseline in HbA1c after 52 weeks of treatment Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 24 and 52 weeks of treatment ; Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 and 52 weeks of treatment; Change from baseline in HbA1c by visit over time •FPG: Change from baseline in FPG after 24 and 52 weeks of treatment; Change from baseline in FPG by visit over time •Body weight and waist circumference: Change from baseline to week 24 and 52 •Systolic and diastolic BP: Change from baseline to week 24 and 52. ;Timepoint(s) of evaluation of this end point: 24 weeks ;Primary end point(s): The change from baseline in HbA1c | — |
Countries
Canada, France, Hong Kong, India, Israel, Malaysia, Netherlands, Philippines, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed