Diabetes Mellitus Type 2Phase 2NCT00461006
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
A Phase 2 study testing Actos and aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 52 sites in 5 countries.
Trial summary
This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Actos and aleglitazar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 52 sitesin 5 countries
- Study dates
- Jun 2007to Sep 2008
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age;
- type 2 diabetes for >=1 month;
- drug naive, or receiving stable oral antihyperglycemic medication;
- HbA1c 6.5-10.0% at screening.
Who cannot join
- type 1 diabetes;
- current or previous treatment with insulin;
- history of renal disease other than diabetic nephropathy;
- uncontrolled hypertension;
- clinically significant cardiovascular disease;
- Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.
Trial locations and contacts
52 sites in 5 countries.
52 sites in 5 countries
United States16 sites
Study site
Altoona, Pennsylvania, 16602
Study site
Arlington, Texas, 76014
Study site
Arlington, Texas, 76017
Study site
Charlotte, North Carolina, 28211
Study site
Dallas, Texas, 75231
Study site
Fresno, California, 93720
Study site
Jacksonville, Florida, 32216-4313
Study site
Jonesboro, Arkansas, 72401
Study site
Los Gatos, California, 95032
Study site
Marion, Ohio, 43302
Study site
Midland, Texas, 79707
Study site
Mission Viejo, California, 92691
Study site
Norfolk, Virginia, 23510
Study site
Omaha, Nebraska, 68131
Study site
Peoria, Arizona, 85381
Study site
San Antonio, Texas, 78284
Russia12 sites
Study site
Moscow, 109472
Study site
Moscow, 125101
Study site
Moscow, 127299
Study site
Moscow, 127486
Study site
Moscow, 129110
Study site
Saint Petersburg, 191025
Study site
Saint Petersburg, 197198
Study site
Saint Petersburg, 198205
Study site
Saint Petersburg, 199106
Study site
Saratov, 410038
Study site
Tyumen, 625023
Study site
Yaroslavl, 150062
Ukraine12 sites
Study site
Dnipro, 49005
Study site
Dnipro, 49060
Study site
Donetsk, 83003
Study site
Donetsk, 83114
Study site
Kharkiv, 61039
Study site
Kharkiv, 61178
Study site
Kiev, 02091
Study site
Kiev, 2091
Study site
Kiev, 2125
Study site
Lugnansk, 91045
Study site
Poltava, 36024
Study site
Ternopil, 46002
Mexico9 sites
Study site
Chihuahua City, 31238
Study site
Chihuahua City, 31328
Study site
Hermosillo, 83067
Study site
Metepec, EMEX52140
Study site
Mexico City, 11650
Study site
Mexico City, 14000
Study site
Mexico City, 14050
Study site
Monterrey, 64000
Study site
Zapopan, 45200
Puerto Rico3 sites
Study site
Manati, 00674
Study site
Ponce, 00717-322
Study site
Toa Baja, 00949
About this study
Official title: A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.
This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Actos, aleglitazar
- 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.
ActosDrug
45mg po daily
aleglitazarDrug
0.6mg po daily
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar | Experimental | Not described Receives: Drug: aleglitazar |
| Actos | Active comparator | Not described Receives: Drug: Actos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in glomerular filtration rate
Measured: 26 weeks
Secondary outcomes (3)
Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
Measured: 26 weeks
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Measured: End of treatment
Adverse events (AEs), laboratory parameters.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2008
- Study completionSep 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 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
- NCT00461006
- Sponsor's protocol ID
- BC20653
- Status last verified
- Jul 2016
- First submitted
- 16 Apr 2007
- Last updated
- 1 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00461006
- Acronym / sponsor ID
- BC20653
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Apr 2007 (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 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aleglitazar | Experimental | Drug: aleglitazar |
| Actos | Active comparator | Drug: Actos |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, 18-75 years of age;
- type 2 diabetes for >=1 month;
- drug naive, or receiving stable oral antihyperglycemic medication;
- HbA1c 6.5-10.0% at screening.
Key exclusion criteria (6 listed)
- type 1 diabetes;
- current or previous treatment with insulin;
- history of renal disease other than diabetic nephropathy;
- uncontrolled hypertension;
- clinically significant cardiovascular 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 |
|---|---|---|
| Actos45mg po daily | Drug | Actos |
| aleglitazar0.6mg po daily | Drug | Aleglitazar |
Primary outcome
Relative change from baseline in glomerular filtration rate
Time frame: 26 weeks
3 secondary outcomes
Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
Time frame: 26 weeks
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Time frame: End of treatment
Adverse events (AEs), laboratory parameters.
Time frame: Throughout study
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 1 Aug 2016.
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
52 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Actos and aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 52 sites in 5 countries.
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 4 inclusion and 6 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Russia, Ukraine, Mexico, Puerto Rico. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Relative change from baseline in glomerular filtration rate (time frame: 26 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 1 Aug 2016.