The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients with Type 2 Diabetes Mellitus - GBD
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2010-019581-82-DE
- Lead Sponsor
- Eli Lilly & Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 693
Inclusion Criteria
Men and nonpregnant women aged =18 years with type 2 diabetes, treated with 1 or more oral antidiabetic medicines, an HbA1c =7.0% and =9.5%, a BP >90/60 mmHg and <140/90 mmHg; if hypertensive on 3 or less antihypertensive medications (same regimen for at least 1 month), and a stable weight with a BMI =23 kg/m2, will be enrolled.
See protocol for full details of inclusion criteria.
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
See protocol for full details of exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that the change from baseline in mean 24-hour systolic blood pressure (SBP) of the 0.75mg and 1.5mg doses of LY2189265 are noninferior to placebo at 16 weeks, as measured by ambulatory blood pressure monitoring (ABPM).;Secondary Objective: See protocol for details;Primary end point(s): The primary measure is change from baseline at 16 weeks in mean 24-hour SBP, as<br>measured by ABPM.
- Secondary Outcome Measures
Name Time Method