Patients with type-2-diabetes mellitus MedDRA version: 13.1 Level: LLT Classification code 10045242 Term: Type II 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
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product N
Sponsors
Boehringer Ingelheim Finland KY
Eligibility
Sex/Gender
All
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 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. 3.HbA1c of = 7.0% (53 mmol/mol) and = 10% (86 mmol/mol) at Visit 1 (screening) 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 = 2 at Visit 1 (screening) and throughout the screening/run-in phase 7.Age = 18 years at Visit 1 (screening) 8.BMI = 45 kg/m2 (Body Mass Index) at Visit 1 (screening) 9.Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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.Mean seated SBP =160 mmHg and/or mean seated DBP=100 mmHg during placebo run-in 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 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 anemia) 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 ? 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, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner 20.Alcohol, drug or confectionary liquorice 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 in the investigator’s opinion 21.Participation in another trial with application of any investigational drug within 30 days prior to informed consent 22.Any other clinical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the efficacy and safety of BI 10773 (10 and 25 mg) compared to placebo on glucose control and BP over 12 weeks in hypertensive patients with T2DM. ;Secondary Objective: The primary endpoint in this study is change from baseline in HbA1c after 12 weeks of treatment Co-primary endpoint is change from baseline in mean 24 hour SBP after 12 weeks of treatment Key secondary endpoint is change from baseline in mean 24 hour DBP after 12 weeks of treatment Other secondary endpoints are defined in protocol section 5.1.1. ;Primary end point(s): The primary endpoint is change from baseline in HbA1c after 12 weeks of treatment. Co-primary endpoint is change from baseline in mean 24-hour SBP after 12 weeks of treatment. ;Timepoint(s) of evaluation of this end point: Primary endpoint and co-primary endpoint are evaluated after 12 weeks of treatment. Throughout the study protocol, the term ‘’baseline’’ refers to the last observation prior to randomization of the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint is change from baseline in mean 24-hour DBP after 12 weeks of treatment Other secondary endpoints are: Proportion of patients with HbA1c -3 mmHg; - Change from baseline in weight of > -2% ;Timepoint(s) of evaluation of this end point: Secondary endpoints are evaluated after 12 weeks of treatment. Throughout the study protocol, the term ‘’baseline’’ refers to the last observation prior to randomization of the patient. | — |
Countries
Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, India, Lebanon, Netherlands, Norway, Sweden, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed