The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients with Type 2 Diabetes Mellitus - GBDN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019581-82-DE

Enrollment

693

Registered

2010-05-21

Start date

2010-10-08

Completion date

Unknown

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Product Name: LY2189265 Product Code: LY2189265 Pharmaceutical Form: Solution for injection Current Sponsor code: LY2189265 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: See protocol for full details of exclusion criteria.

Design outcomes

Primary

Measure	Time frame
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 measured by ABPM.	—

Measure

Time frame

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 measured by ABPM.

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Countries

Czech Republic, Denmark, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026