A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
NCT ID: NCT01398267
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2011-08-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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1
aleglitazar
150 mcg orally daily, 4 weeks (Day 15 to Day 43)
lisinopril
20 mg orally daily, 6 weeks (Day 1 to Day 43)
2
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Chula Vista, California, United States
Omaha, Nebraska, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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BP25328
Identifier Type: -
Identifier Source: org_study_id