A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone

February 22, 2017 updated by: Hoffmann-La Roche

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. 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)

200

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

  • Argentina
      • Buenos Aires, Argentina, 1056
      • Caba, Argentina, C1428DCO
      • Rosario, Argentina, S2000CXP
  • Mexico
      • Cuernavaca, Mexico, 62250
      • Culiacan, Mexico, 80020
      • Guadalajara, Mexico, 44650
      • Mexico City, Mexico, 11650
      • Pachuca, Mexico, 42060
      • Tampico, Mexico, 89000
  • United States
    • California
      • Chino, California, United States, 91710
      • Hawaiian Gardens, California, United States, 90716
      • Los Angeles, California, United States, 90057
      • Santa Ana, California, United States, 92701
      • Thousand Oaks, California, United States, 91360
      • West Hills, California, United States, 91307
    • Florida
      • Kissimmee, Florida, United States, 34741
    • Georgia
      • Atlanta, Georgia, United States, 30338
    • Illinois
      • Chicago, Illinois, United States, 60607
    • Indiana
      • Avon, Indiana, United States, 46123
    • Maryland
      • Bethesda, Maryland, United States, 20817
    • Missouri
      • Springfield, Missouri, United States, 65807
    • New Jersey
      • Toms River, New Jersey, United States, 08753
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
      • Beaver, Pennsylvania, United States, 15009
      • Morrisville, Pennsylvania, United States, 19067
      • Scranton, Pennsylvania, United States, 18510
      • Tipton, Pennsylvania, United States, 16684
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
    • Texas
      • Dallas, Texas, United States, 75230
    • Virginia
      • Richmond, Virginia, United States, 23249
    • 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
  • Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
  • 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 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: placebo+metformin
Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
EXPERIMENTAL: aleglitazar
Drug: aleglitazar+metformin
150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)

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

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

October 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 (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC28035

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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