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Diabetes Mellitus Type 2Phase 3NCT01691755

A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

A Phase 3 study testing aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 34 sites in 2 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 multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
196 participants
Where
34 sitesin 2 countries
Study dates
Nov 2012to Sep 2013
Phase
Phase 3
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
  • Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
  • Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
  • HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
  • Fasting plasma glucose </=240 mg/dL at pre-randomization visit
  • Agreement to maintain diet and exercise habits during the study

Who cannot join

  • Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
  • Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist
  • Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
  • Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States23 sites

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Avon, Indiana, 46123

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chino, California, 91710

  • Study site

    City of Saint Peters, Missouri, 63376

  • Study site

    Cooper City, Florida, 33024

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Knoxville, Tennessee, 37919

  • Study site

    Los Angeles, California, 90057

  • Study site

    Portland, Oregon, 97239

  • Study site

    Santa Ana, California, 92701

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    Spokane, Washington, 99202

  • Study site

    Thousand Oaks, California, 91360

  • Study site

    Tipton, Pennsylvania, 16684

  • Study site

    Upland, California, 91786

  • Study site

    West Hills, California, 91307

Other trials in United States

Mexico11 sites

  • Study site

    Aguascaliente, 20230

  • Study site

    Cuernavaca, 62250

  • Study site

    Culiacán, 80020

  • Study site

    Durango, 34000

  • Study site

    Durango, 34080

  • Study site

    Guadalajara, 44600

  • Study site

    Mexico City, 11650

  • Study site

    Monterrey, 64460

  • Study site

    Pachuca, 42090

  • Study site

    Querétaro, 76000

  • Study site

    Tampico, 89000

Other trials in Mexico

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

Being tested
Placebo, 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.

  • PlaceboDrug

    oral doses once a day for 26 weeks

  • aleglitazarDrug

    150 mcg orally once a day for 26 weeks

Study groups in NCT01691755
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
aleglitazarExperimentalNot described
Receives: Drug: aleglitazar

What is being measured

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

  1. Change from baseline in hemoglobin HbA1c

    Measured: From baseline to week 26

Secondary outcomes (6)

  1. Change in lipid profile

    Measured: From baseline to week 26

  2. Change from baseline in fasting plasma glucose

    Measured: From baseline to week 26

  3. Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)

    Measured: From baseline to week 26

  4. Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)

    Measured: From baseline to week 26

  5. Change from baseline in homeostatic index of beta cell function (HOMA-BCF)

    Measured: From baseline to week 26

  6. Safety: incidence of adverse events

    Measured: 30 weeks (26 weeks treatment and 4 weeks follow-up)

Timeline

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

  1. First posted25 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691755
Sponsor's protocol ID
BC28034
Status last verified
Aug 2016
First submitted
20 Sep 2012
Last updated
11 Aug 2016
Results posted
No

Publications

  • Henry RR, Buse JB, Wu H, Durrwell L, Mingrino R, Jaekel K, El Azzouzi B, Andjelkovic M, Herz M. Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials. Diabetes Obes Metab. 2015 Jun;17(6):560-565. doi: 10.1111/dom.12455. Epub 2015 Apr 8.

    PubMed 25728612

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aleglitazar in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 34 sites in 2 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 6 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 11 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 34 sites in United States, Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change from baseline in hemoglobin HbA1c (time frame: From baseline to week 26). 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 NCT01691755, 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 11 Aug 2016.

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