Health Condition 1: null- Diabetes with Hypertension
Conditions
Interventions
Intervention1: BI 10773: 25 mg p.o., once daily for 12 weeks
Intervention2: BI 10773: 10 mg p.o., once daily for 12 weeks
Intervention3: BI 10773: Placebo p.o., once daily for 12 weeks
Control Inte
Sponsors
BoehringerIngelheim India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of T2DM prior to informed consent 2. Male and female patients on diet and exercise regimen who are: drug-naïve, (defined as absence of any oral antidiabetic therapy , GLP-1 analog or insulin for 12 weeks, 16 weeks for pioglitazone prior to randomisation) or pre-treated with any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation Pre-existing antidiabetic therapy doses should be unchanged for 12 weeks (16 weeks for pioglitazone) prior to randomisation and prescribed insulin dose should not be changed within 12 weeks prior to randomization by more than 10% from the baseline dose at randomisation (Visit 3). 3. HbA1c of >= 7.0% (53 mmol/mol) and 4. Mean seated SBP 130-159 mmHg and DBP 80-99 mmHg at Visit 1 (screening) 5. Treatment with stable doses of antihypertensive medication >= 4 weeks at Visit 1 (screening) and throughout the screening/run-in phase 6. Number of previous antihypertensive medication throughout the screening/run-in phase 7. Age >= 18 years at Visit 1 (screening) 8. BMI 9. 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. Mean seated SBP >=160 mmHg and/or mean seated DBP>=100 mmHg during placebo runin visit and confirmed by a second measurement (not on the same day) preferably within one day 3. Upper arm circumference that exceeds the upper circumference level of the cuff size of either ABPM and/or BP measurement device used in the study and/or unsuccessful completion of ABPM testing prior randomisation. 4. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m. 5. Current treatment and/or treatment within the last 16 weeks with Rosiglitazone 6. Known or suspected secondary hypertension (e.g. renal artery stenosis, phaeochromocytoma) 7. History or evidence of hypertensive retinopathy (Keith-Wagener grade III or IV) and/or hypertensive encephalopathy 8. Clinically significant valvular heart disease or severe aortic stenosis 9. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent 10. 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 11. Impaired renal function, defined as eGFR 60 ml/min (moderate renal impairment, MDRD formula) as determined during screening and/or run-in phase 12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 13. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 14. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia) 15. Any contraindications to background antidiabetic medications according to the local label 16. Any contraindications to background antihypertensive medications according to the local label 17. Treatment with anti-obesity drugs 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 18. 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 T2D 19. Pre-menopausal women (last menstruation - 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 uterinedevices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner 20. Alcohol,
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint is change from baseline in mean 24-hour DBP after 12 weeks of treatment Timepoint: 12 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in this study is change from baseline in HbA1c after 12 weeks of treatment. Throughout the study protocol, the term â??â??baselineâ??â?? refers to the last observation prior to randomization of the patient. Co-primary endpoint is change from baseline in mean 24-hour SBP after 12 weeks of treatment.Timepoint: 12 weeks | — |
Countries
Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Lebanon, Netherlands, Norway, United States of America
Contacts
Public ContactShoma Das
Boehringer-Ingelheim India Pvt Ltd
Outcome results
None listed