Health Condition 1: null- Type 2 Diabetes Mellites
Conditions
Interventions
Intervention1: BI 10773 tablets: 10 mg once daily for 24 weeks
Intervention2: BI 10773 tablets: 25 mg once daily for 24 weeks
Intervention3: BI 10773 tablets: 25 mg once daily open label for 24 weeks
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 diet and exercise regimen who are drug-naïve, defined as absence of any oral or injectable anti-diabetes therapy for 12 weeks prior to randomisation or start of active open-label treatment (25 mg BI 10773) 3. HbA1c - ≥ 7.0% and 10.0% at visit 1 (screening) in order to be eligible for the open-label BI 10773 arm 4. Age ≥ 20 (Japan) Age ≥ 18 (countries other than Japan) 5. BMI (Body Mass Index) ≤ 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
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. Myocardial infarction, stroke or TIA within 3 months prior to informed consent 3. 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 phase 4. Impaired renal function, defined as eGFR50 ml/min (moderate to severe renal impairment; MDRD formula) as determined during screening and/or run-in phase 5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 6. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 7. Contraindications to sitagliptin according to the local label 8. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia) 9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation or start of active open-label treatment (25 mg BI 10773) 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 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, 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 |
|---|---|
| Change from baseline in HbA1c after 24 weeks of treatment (%)Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight: Change from baseline to week 24Timepoint: 24 weeks;Systolic and diastolic blood pressure (SBP and DBP): Change from baseline to week 24Timepoint: 24 weeks | — |
Countries
Belgium, Canada, China, Germany, India, Japan, Singapore, Swaziland, United Kingdom, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Private Limited
Outcome results
None listed