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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398267
• Other study ID #: BP25328
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2011
• Last updated: November 1, 2016
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• aleglitazar
150 mcg orally daily, 4 weeks (Day 15 to Day 43)
• lisinopril
20 mg orally daily, 6 weeks (Day 1 to Day 43)
• placebo
aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate (mGFR), measured as iohexol clearance		4 weeks	No
Secondary	Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])		4 weeks	No
Secondary	Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)		4 weeks	No
Secondary	Electrolyte blood/urine concentrations		4 weeks	No
Secondary	Renin-angiotensin system: plasma renin/aldosterone levels)		4 weeks	No
Secondary	Anti-diuretic hormone (ADH) blood levels		4 weeks	No
Secondary	Safety: Incidence of adverse events		up to 18 weeks	No
Secondary	Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])		4 weeks	No
Secondary	Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril		4 weeks	No
Secondary	High density lipoprotein-cholesterol (HDL-C) blood levels		4 weeks	No