Diabetes Mellitus Type 2Phase 1NCT01398267
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
A Phase 1 study testing aleglitazar and lisinopril in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- aleglitazar and lisinopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Chula Vista, California, 91911
Study site
Dallas, Texas, 75247
Study site
Omaha, Nebraska, 68154
Study site
San Antonio, Texas, 78209
About this study
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
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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- aleglitazar, lisinopril, placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aleglitazarDrug
150 mcg orally daily, 4 weeks (Day 15 to Day 43)
lisinoprilDrug
20 mg orally daily, 6 weeks (Day 1 to Day 43)
placeboDrug
aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: aleglitazar; Drug: lisinopril |
| 2 | Placebo comparator | Not described Receives: Drug: lisinopril; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (mGFR), measured as iohexol clearance
Measured: 4 weeks
Secondary outcomes (9)
Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])
Measured: 4 weeks
Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)
Measured: 4 weeks
Electrolyte blood/urine concentrations
Measured: 4 weeks
Renin-angiotensin system: plasma renin/aldosterone levels)
Measured: 4 weeks
Anti-diuretic hormone (ADH) blood levels
Measured: 4 weeks
Safety: Incidence of adverse events
Measured: up to 18 weeks
Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])
Measured: 4 weeks
Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril
Measured: 4 weeks
High density lipoprotein-cholesterol (HDL-C) blood levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398267
- Sponsor's protocol ID
- BP25328
- Status last verified
- Nov 2016
- First submitted
- 19 Jul 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01398267
- Acronym / sponsor ID
- BP25328
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aleglitazar, Drug: lisinopril |
| 2 | Placebo comparator | Drug: lisinopril, Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aleglitazar150 mcg orally daily, 4 weeks (Day 15 to Day 43) | Drug | 1 |
| lisinopril20 mg orally daily, 6 weeks (Day 1 to Day 43) | Drug | 1, 2 |
| placeboaleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43) | Drug | 2 |
Primary outcome
Glomerular filtration rate (mGFR), measured as iohexol clearance
Time frame: 4 weeks
9 secondary outcomes
Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])
Time frame: 4 weeks
Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)
Time frame: 4 weeks
Electrolyte blood/urine concentrations
Time frame: 4 weeks
Renin-angiotensin system: plasma renin/aldosterone levels)
Time frame: 4 weeks
Anti-diuretic hormone (ADH) blood levels
Time frame: 4 weeks
Safety: Incidence of adverse events
Time frame: up to 18 weeks
Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])
Time frame: 4 weeks
Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril
Time frame: 4 weeks
High density lipoprotein-cholesterol (HDL-C) blood levels
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aleglitazar and lisinopril in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (mGFR), measured as iohexol clearance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.