A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | August 2011 |
| End Date: | October 2012 |
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Aleglitazar 150 µg in Type 2 Diabetic Patients Treated With Lisinopril 20 mg on Renal Function, the Renin-angiotensin System and the Pharmacokinetics of Lisinopril
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the
effect of aleglitazar on renal function, the renin-angiotensin system and the
pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with
lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be
randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to
lisinopril for 4 weeks.
effect of aleglitazar on renal function, the renin-angiotensin system and the
pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with
lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be
randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to
lisinopril for 4 weeks.
Inclusion Criteria:
- Adult male and female patients, 18 to 65 years of age, inclusive
- Diabetes mellitus Type 2, diagnosed at least 3 months before screening
- Treated with stable dose of metformin for at least 4 weeks prior to screening
- Treated with stable dose of Angiotensin-converting enzyme inhibitor (ACEI) for at
least 4 weeks prior to screening
- Body mass index (BMI) 18 to 38 kg/m2, inclusive
Exclusion Criteria:
- Positive for HIV-1, HIV-2, hepatitis B or hepatitis C infection
- Pregnant or lactating females
- Type 1 diabetes or secondary from of diabetes
- History or evidence of proliferative diabetic retinopathy or clinically significant
neuropathy
- Clinically significant hepatic disease
- Clinically significant renal impairment
- History or evidence of clinically significant cardio-vascular disease or disorder
- Acute infection or current malignancy requiring treatment except for excised basal
cell carcinoma
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials