Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 19, 2011
Last updated: March 2, 2015
Last verified: March 2015

July 19, 2011
March 2, 2015
August 2011
October 2012   (final data collection date for primary outcome measure)
Glomerular filtration rate (mGFR), measured as iohexol clearance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01398267 on Archive Site
  • Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD]) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Electrolyte blood/urine concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Renin-angiotensin system: plasma renin/aldosterone levels) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Anti-diuretic hormone (ADH) blood levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
  • Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC]) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • High density lipoprotein-cholesterol (HDL-C) blood levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
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

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.

Not Provided
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Diabetes Mellitus, Type 2
  • Drug: aleglitazar
    150 mcg orally daily, 4 weeks (Day 15 to Day 43)
  • Drug: lisinopril
    20 mg orally daily, 6 weeks (Day 1 to Day 43)
  • Drug: placebo
    aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)
  • Experimental: 1
    • Drug: aleglitazar
    • Drug: lisinopril
  • Placebo Comparator: 2
    • Drug: lisinopril
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
October 2012   (final data collection date for primary outcome measure)

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP