NCT01398267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

July 19, 2011

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate (mGFR), measured as iohexol clearance

    4 weeks

Secondary Outcomes (9)

  • Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])

    4 weeks

  • Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)

    4 weeks

  • Electrolyte blood/urine concentrations

    4 weeks

  • Renin-angiotensin system: plasma renin/aldosterone levels)

    4 weeks

  • Anti-diuretic hormone (ADH) blood levels

    4 weeks

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: aleglitazarDrug: lisinopril

2

PLACEBO COMPARATOR
Drug: lisinoprilDrug: placebo

Interventions

aleglitazarDRUG

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

1
lisinoprilDRUG

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

12
placeboDRUG

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Chula Vista, California, 91911, United States

Location

Unknown Facility

Omaha, Nebraska, 68154, United States

Location

Unknown Facility

Dallas, Texas, 75247, United States

Location

Unknown Facility

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazarLisinopril

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(4)