Status:
COMPLETED
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01398267
Start Date
August 1 2011
End Date
October 1 2012
Last Update
November 2 2016
Active Locations (4)
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1
Chula Vista, California, United States, 91911
2
Omaha, Nebraska, United States, 68154
3
Dallas, Texas, United States, 75247
4
San Antonio, Texas, United States, 78209