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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398267
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: aleglitazar Drug: lisinopril Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Glomerular filtration rate (mGFR), measured as iohexol clearance [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD]) [ Time Frame: 4 weeks ]
  2. Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations) [ Time Frame: 4 weeks ]
  3. Electrolyte blood/urine concentrations [ Time Frame: 4 weeks ]
  4. Renin-angiotensin system: plasma renin/aldosterone levels) [ Time Frame: 4 weeks ]
  5. Anti-diuretic hormone (ADH) blood levels [ Time Frame: 4 weeks ]
  6. Safety: Incidence of adverse events [ Time Frame: up to 18 weeks ]
  7. Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC]) [ Time Frame: 4 weeks ]
  8. Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril [ Time Frame: 4 weeks ]
  9. High density lipoprotein-cholesterol (HDL-C) blood levels [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398267

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
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01398267     History of Changes
Other Study ID Numbers: BP25328
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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