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A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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 g 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

Chula Vista, California 91911, United States

Omaha, Nebraska 68154, United States

Dallas, Texas 75247, United States

San Antonio, Texas 78209, United States

Additional Information

Starting date: August 2011
Last updated: August 17, 2015

Page last updated: August 23, 2015

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