The trial number is 1245.48, it is a double-blind, placebo-controlled, parallel-group trial to evaluate the safety and efficacy of Boehringer-Ingelheim product BI10773 (10 mg, 25 mg) in hypertensive patients with type 2 diabetes mellitus.
- Conditions
- Health Condition 1: null- Diabetes with Hypertension
- Registration Number
- CTRI/2012/04/002555
- Lead Sponsor
- BoehringerIngelheim India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 816
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 < 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
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 <= 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 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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint in this study is change from baseline in HbA1c after 12 weeks of <br/ ><br>treatment. Throughout the study protocol, the term â??â??baselineâ??â?? refers to the last observation <br/ ><br>prior to randomization of the patient. <br/ ><br>Co-primary endpoint is change from baseline in mean 24-hour SBP after 12 weeks of <br/ ><br>treatment.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Key secondary endpoint is change from baseline in mean 24-hour DBP after 12 weeks of <br/ ><br>treatment <br/ ><br>Timepoint: 12 weeks