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

August 9, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Aguascaliente, Mexico, 20230
      • Cuernavaca, Mexico, 62250
      • Culiacan, Mexico, 80020
      • Durango, Mexico, 34000
      • Durango, Mexico, 34080
      • Guadalajara, Mexico, 44600
      • Mexico City, Mexico, 11650
      • Monterrey, Mexico, 64460
      • Pachuca, Mexico, 42090
      • Queretaro, Mexico, 76000
      • Tampico, Mexico, 89000
  • United States
    • California
      • Chino, California, United States, 91710
      • Los Angeles, California, United States, 90057
      • Santa Ana, California, United States, 92701
      • Thousand Oaks, California, United States, 91360
      • Upland, California, United States, 91786
      • West Hills, California, United States, 91307
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Cooper City, Florida, United States, 33024
      • Coral Gables, Florida, United States, 33134
      • Jacksonville, Florida, United States, 32216
      • Kissimmee, Florida, United States, 34741
    • Georgia
      • Atlanta, Georgia, United States, 30338
    • Illinois
      • Chicago, Illinois, United States, 60607
    • Indiana
      • Avon, Indiana, United States, 46123
    • Missouri
      • St Peters, Missouri, United States, 63376
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
      • Scranton, Pennsylvania, United States, 18510
      • Tipton, Pennsylvania, United States, 16684
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
    • Washington
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral doses once a day for 26 weeks
Experimental: aleglitazar
Drug: aleglitazar
150 mcg orally once a day for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in hemoglobin HbA1c
Time Frame: From baseline to week 26
From baseline to week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in lipid profile
Time Frame: From baseline to week 26
From baseline to week 26
Change from baseline in fasting plasma glucose
Time Frame: From baseline to week 26
From baseline to week 26
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Time Frame: From baseline to week 26
From baseline to week 26
Safety: incidence of adverse events
Time Frame: 30 weeks (26 weeks treatment and 4 weeks follow-up)
30 weeks (26 weeks treatment and 4 weeks follow-up)
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
Time Frame: From baseline to week 26
From baseline to week 26
Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)
Time Frame: From baseline to week 26
From baseline to week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC28034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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