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NCT Number: NCT01398267

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aleglitazar

Drug

150 mcg orally daily, 4 weeks (Day 15 to Day 43)

Lisinopril

Drug

20 mg orally daily, 6 weeks (Day 1 to Day 43)

Placebo

Drug

aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)

Primary outcomes

  1. Glomerular filtration rate (mGFR), measured as iohexol clearance

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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