None listed
Conditions
Interventions
Intervention1: BI 10773: 10 mg, Once Daily
Intervention2: BI 10773: 25 mg, Once Daily
Control Intervention1: Placebo: 10 mg or 25 mg, Once Daily
Sponsors
Boehringer Ingelheim Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent and a eGFR of <90 ml/min, as determined during screening and the run-in phase, using the Modification of Diet in Renal Disease (MDRD) equation. 2. Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy (excluding only SGLT-2 inhibitors) and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation. ? Metformin therapy should be &#8805; 1500 mg/day or on the maximum tolerated dose or maximum dose according to local labelling ? The prescribed insulin dose should not be changed within the 12 weeks prior to randomisation by +/- 10% from the baseline value at randomisation ? Pioglitazone therapy should be &#8805;30 mg/day or maximum dose according to local labelling ? Sulphonylurea therapy should be &#8805;half the recommended maximal dose according to local labelling. 3. HbA1c of &#8805;7.0% and <10.0% at Visit 1 (screening). 4. Age &#8805;18 years (Restricted to patients <= 65 years of age as per upper age limit imposed by the DCG(I) for patients recruited in India). 5. BMI &#8804;45 kg/m2 (Body Mass Index) at Visit 1 (screening). 6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
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. Myocardial infarction, 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 (e.g. sibutramine, orlistat) 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 &#8804;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. Participation in another trial with an investigational drug within 30 days prior to informed consent. 17. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c after 24weeks of treatmentTimepoint: Baseline and 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight and waist circumference: Change from baseline to week 24 and 52Timepoint: Baseline, 24 Weeks and 52 Weeks;Change from baseline in FPG after 24 and 52 weeks of treatmenTimepoint: Baseline, 24 Weeks and 52 Weeks;Change from baseline in FPG by visit over timeTimepoint: Ongoing;Change from baseline in HbA1c after 52 weeks of treatmentTimepoint: Baseline and 52 Weeks;Change from baseline in HbA1c by visit over timeTimepoint: Ongoing;Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 and 52 weeks of treatmentTimepoint: Baseline, 24 Weeks and 52 Weeks;Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 24 and 52 weeks of treatmentTimepoint: Baseline, 24 Weeks and 52 Weeks;Systolic and diastolic BP: Change from baseline to week 24 and 52.Timepoint: Baseline, 24 Weeks and 52 Weeks | — |
Countries
Canada, France, India, Israel, Malaysia, Netherlands, Other, Philippines, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt. Ltd.
Outcome results
None listed