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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01398267
First received: July 19, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: aleglitazar
Drug: lisinopril
Drug: placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Glomerular filtration rate (mGFR), measured as iohexol clearance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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)
Placebo Comparator: 2 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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398267

Locations
United States, California
Chula Vista, California, United States, 91911
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, Texas
Dallas, Texas, United States, 75247
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01398267     History of Changes
Other Study ID Numbers: BP25328
Study First Received: July 19, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014