12 week efficacy and safety study of BI 10773 in hypertensive patients with type 2 diabetes

• Conditions: Patients with type-2-diabetes Mellitus; MedDRA version: 13.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-000347-25-DK
• Lead Sponsor: Boehringer Ingelheim Danmark A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-12
• Last Update Posted: 29 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 816

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 o

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified