A Study of Aleglitazar in Patients With Type 2 Diabetes

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 2

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

  • Greece
      • Athens, Greece, 12462
      • Thessaloniki, Greece, 56429
  • Hong Kong
      • Hong Kong, Hong Kong
  • Italy
      • Bologna, Italy, 40138
      • Genova, Italy, 16132
      • Napoli, Italy, 80100
      • Olbia, Italy, 07026
      • Pavia, Italy, 27100
      • Perugia, Italy, 06126
      • Roma, Italy, 00133
      • Siena, Italy, 53100
      • Torino, Italy, 10126
  • Mexico
      • Aguascalientes, Mexico, 20230
      • Chihuahua, Mexico, 31238
      • Cuernavaca, Mexico, 62250
      • Durango, Mexico, 34080
      • Guadalajara, Mexico, 44340
      • Guadalajara, Mexico, 44650
      • Mexico City, Mexico, 10700
      • Monterrey, Mexico, 66260
      • Pachuca, Mexico, 42086
  • Romania
      • Bucharest, Romania
      • Bucharest, Romania, 020475
      • Cluj-napoca, Romania, 400006
      • Galati, Romania, 800352
      • Ploiesti, Romania, 100163
  • Russian Federation
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 129090
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 129327
      • Moscow, Russian Federation, 125315
      • Saratov, Russian Federation, 410038
      • St Petersburg, Russian Federation, 197198
      • St Petersburg, Russian Federation, 197089
  • Serbia
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
      • NIS, Serbia, 18000
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Phoenix, Arizona, United States, 85029
    • California
      • Beverly Hills, California, United States, 90211
      • Palm Springs, California, United States, 92262
      • San Diego, California, United States, 92161
    • Florida
      • Chiefland, Florida, United States, 32626
      • Hollywood, Florida, United States, 33023
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
    • Maryland
      • Baltimore, Maryland, United States, 21229
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
    • New Jersey
      • Hamilton, New Jersey, United States, 08610
    • New York
      • New Hyde Park, New York, United States, 11042
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
    • Washington
      • Spokane, Washington, United States, 99216

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes, diagnosed >=1 month of screening;
  • either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
  • HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.

Exclusion Criteria:

  • type 1 diabetes;
  • currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
  • clinically significant cardiovascular disease;
  • Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.

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
po daily
Active Comparator: Actos
Drug: Actos
45mg po daily
Experimental: Aleglitazar 1
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: Aleglitazar 2
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: Aleglitazar 3
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: Aleglitazar 4
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in Hemoglobin A1c (HbA1c)
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.
Time Frame: 16 weeks
16 weeks
Adverse Events (AEs), laboratory parameters.
Time Frame: Throughout study
Throughout study

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, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM17864

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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