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AzTrials

Diabetes Mellitus Type 2Phase 2NCT01043029

A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

A Phase 2 study testing aleglitazar and pioglitazone in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 80 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
aleglitazar and pioglitazone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
80 sitesin 13 countries
Study dates
May 2010to Jul 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients >/= 18 years of age
  • Diabetes mellitus, Type 2
  • Moderately impaired kidney function
  • Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
  • BMI 25-35

Who cannot join

  • Current or previous treatment with a thiazolidinedione
  • Current or previous treatment with insulin
  • Treatment with fibrates <3 months prior to screening
  • History of renal disease other than diabetic nephropathy

Trial locations and contacts

80 sites in 13 countries.

80 sites in 13 countries

Germany13 sites

  • Study site

    Aschaffenburg, 63739

  • Study site

    Berlin, 10115

  • Study site

    Damme, 49401

  • Study site

    Dresden, 01307

  • Study site

    Essen, 45359

  • Study site

    Falkensee, 14612

  • Study site

    Mainz, 55116

  • Study site

    Münster, 48145

  • Study site

    Neuwied, 56564

  • Study site

    Reichenbach, 08468

  • Study site

    Rostock, 18059

  • Study site

    Sulzbach-Rosenberg, 92237

  • Study site

    Würzburg, 97072

Other trials in Germany

Russia12 sites

  • Study site

    Chelyabinsk, 454047

  • Study site

    Moscow, 119121

  • Study site

    Moscow, 121069

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 127299

  • Study site

    Moscow, 129110

  • Study site

    Saint Petersburg, 194156

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 195257

  • Study site

    Saint Petersburg, 197089

  • Study site

    Saratov, 140018

  • Study site

    Yaroslavl, 150062

Other trials in Russia

Hungary10 sites

  • Study site

    Baja, 6500

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1045

  • Study site

    Budapest, 1135

  • Study site

    Debrecen, 4032

  • Study site

    Kecskemét, 6001

  • Study site

    Miskolc, 3526

  • Study site

    Sátoraljaújhely, 3980

  • Study site

    Szeged, 6720

  • Study site

    Szekszárd, 7100

Other trials in Hungary

Mexico8 sites

  • Study site

    Aguascaliente, 20230

  • Study site

    Chihuahua City, 31238

  • Study site

    Cuernavaca, 62250

  • Study site

    Durango, 34080

  • Study site

    Guadalajara, 44600

  • Study site

    Guadalajara, 44650

  • Study site

    Pachuca, 42060

  • Study site

    Pachuca, 42090

Other trials in Mexico

Australia7 sites

  • Study site

    Brisbane, Queensland, 4075

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Elizabeth Vale, South Australia, 5112

  • Study site

    Launceston, Tasmania, 7001

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Richmond, South Australia, 3121

  • Study site

    St Leonards, New South Wales, 2065

Other trials in Australia

Romania6 sites

  • Study site

    Bucharest, 020475

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Iași, 700 503

  • Study site

    Ploieşti, 100163

  • Study site

    Sibiu, 550245

  • Study site

    Târgu Mureş, 540142

Other trials in Romania

Brazil5 sites

  • Study site

    Fortaleza, Ceará, 60135-170

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • Study site

    São Paulo, São Paulo, 01221-020

  • Study site

    São Paulo, São Paulo, 04022-001

  • Study site

    São Paulo, São Paulo, 04231-030

Other trials in Brazil

Italy5 sites

  • Study site

    Bergamo, Lombardy, 20128

  • Study site

    Cusano Milanino, Lombardy, 20095

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Pavia, Lombardy, 27100

Other trials in Italy

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Medellin-Antioquia

Other trials in Colombia

Slovakia4 sites

  • Study site

    Bratislava, 821 02

  • Study site

    Dolný Kubín, 026 01

  • Study site

    Levice, 034 01

  • Study site

    Lučenec, 984 01

Other trials in Slovakia

Peru3 sites

  • Study site

    Arequipa, Cercado

  • Study site

    Lima, 11

  • Study site

    Lima, LIMA 29

Other trials in Peru

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Tuenmen, 852

Other trials in Hong Kong

El Salvador1 site

  • Study site

    San Salvador

Other trials in El Salvador

About this study

Official title: Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Being tested
aleglitazar, pioglitazone
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

    Aleglitazar 150 mcg po daily for 52 weeks

  • pioglitazoneDrug

    Pioglitazone 45 mg po daily for 52 weeks

Study groups in NCT01043029
Study groupRoleWhat they receive
aleglitazarExperimentalNot described
Receives: Drug: aleglitazar
pioglitazoneActive comparatorNot described
Receives: Drug: pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal function: estimated glomerular filtration rate

    Measured: Week 60

Secondary outcomes (3)

  1. Safety, Tolerability: Adverse events (AEs), laboratory parameters

    Measured: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60

  2. Renal function: estimated glomerular filtration rate

    Measured: Week 52

  3. Effect on blood hemoglobin

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01043029
Sponsor's protocol ID
BC22419
Other IDs
2009-012270-12, 2009
Status last verified
Nov 2016
First submitted
5 Jan 2010
Last updated
2 Nov 2016
Results posted
No

Publications

  • Ruilope L, Hanefeld M, Lincoff AM, Viberti G, Meyer-Reigner S, Mudie N, Wieczorek Kirk D, Malmberg K, Herz M. Effects of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on renal function in patients with stage 3 chronic kidney disease and type 2 diabetes: a Phase IIb, randomized study. BMC Nephrol. 2014 Nov 18;15:180. doi: 10.1186/1471-2369-15-180.

    PubMed 25407798

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aleglitazar and pioglitazone in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 80 sites in 13 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 5 inclusion and 4 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 80 sites in Germany, Russia, Hungary, Mexico, Australia and 8 more countries. 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?

Renal function: estimated glomerular filtration rate (time frame: Week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01043029, which also lists 1 linked publication.

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.

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