At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus diagnosed per WHO criteria
- ✓Using diet and exercise alone, or metformin ≥1000 mg/day (or <1000 mg if documented intolerance) for ≥2 months before screening
- ✓HbA1c 6.5–8.5% at screening
- ✓Mean blood pressure >90/60 mmHg and <140/90 mmHg at screening
- ✕Severe gastrointestinal disease significantly affecting gastric emptying or motility
- ✕History or current diagnosis of pancreatitis
- ✕Acute or chronic hepatitis, signs/symptoms of liver disease, or ALT >2.5× upper limit of normal
- ✕Elevated total bilirubin (>2× ULN), clinical signs of cirrhosis, or history of cirrhosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of LY2409021 on Blood Pressure and Pulse Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating LY2409021, Placebo, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 270 participants across 30 sites in 5 countries.
Detailed Summary
The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.
Study Details
Timeline
Interventions
Administered orally
Administered orally
Administered as background therapy.