A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: aleglitazar (Drug); lisinopril (Drug); placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Overall contact:
Please reference Study ID Number: BP25328, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
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 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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Glomerular filtration rate (mGFR), measured as iohexol clearance
Secondary outcome: Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations) Electrolyte blood/urine concentrations Renin-angiotensin system: plasma renin/aldosterone levels) Anti-diuretic hormone (ADH) blood levels Safety: Incidence of adverse events Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC]) Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril High density lipoprotein-cholesterol (HDL-C) blood levels
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Please reference Study ID Number: BP25328, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
Omaha, Nebraska 68154, United States; Not yet recruiting
San Antonio, Texas 78209, United States; Recruiting
Additional Information
Starting date: August 2011
Last updated: December 5, 2011
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