Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: BI 10773 tablets: 10 mg once daily
Intervention2: BI 10773 Tablets: 25 mg Once Daily
Intervention3: BI 10773 tablets: 25 mg once daily open label
Control Intervention1: Placebo matching
Sponsors
Boehringer Ingelheim Pharma GmbH Co KG
Eli Lilly and Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on a diet and exercise regimen who are pre treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation. Minimum dose for metformin: greater than or equal to 1500 mg per day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: greater than or equal to half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label 3. HbA1c of greater than or equal to 7.0 per cent and less than or equal to 11 per cent at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of greater than 11 per cent at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773) 4. Age in between 18 and 65 5. Body Mass Index BMI less than or equal to 45 kg per meter square (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 greater than 240 mg per dl (greater than 13.3 mmol per 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 randomisation except those mentioned in inclusion criterion 2 3. Myocardial infarction, 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 times upper limit of normal (ULN) as determined during screening and/or run-in phase 5. Impaired renal function, defined as eGFR less than 30 ml per min (severe renal impairment) as determined during screening and/or run-in phase 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. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy 9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia) 10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 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 Typ 2 Diabetes 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, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised 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. Participation in another trial with an investigational drug within 30 days prior to informed consent 15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c after 24 weeks.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of a treat to target response, (i.e. an HbA1c under treatment of < 7.0%)Timepoint: 24 weeks;Occurrence of relative efficacy response (HbA1c lowering by at least 0.5%)Timepoint: 24 weeks;The body weight (kg) change from baseline after 24 weeks.Timepoint: 24 weeks;The change in fasting plasma glucose (FPG), waist and systolic and diastolic blood pressure from baseline to week 24Timepoint: 24 weeks;The change in HbA1c and FPG by visit over timeTimepoint: 24 weeks;The composite endpoint of the following conditions at week 24: HbA1c lowering by a least 0.5%, lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%.Timepoint: 24 weeks;The mean daily plasma glucose (MDG) change from baseline after 24 weeks of treatment.Timepoint: 24 weeks | — |
Countries
Canada, China, France, Germany, India, Mexico, Republic of Korea, Slovakia, Slovenia, Taiwan, Turkey, United States of America
Contacts
Public ContactDr Viraj Suvarna
Boehringer Ingelheim India Pvt. Ltd.
Outcome results
None listed