A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
Completed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus Type 2
In brief
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.
Key facts
- Study ID
- NCT01398267
- Run by
- Hoffmann-La Roche
- People needed
- 55
- Starts
- 2011-08-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Chula Vista, California, United States
- Study site — Omaha, Nebraska, United States
- Study site — Dallas, Texas, United States
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.