A Study of Aleglitazar in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00388518
First received: October 16, 2006
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This 6 arm study will assess the efficacy, safety, tolerability and pharmacokine tics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be r andomised 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 admini stered starting from a dose of 0.05mg po daily, and Actos will be administered a t a dose of 45mg once daily. The anticipated time on study treatment is 3-12 mon ths, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Actos
Drug: Placebo
Drug: aleglitazar
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change from baseline in FPG, HbAlc response rate, insulin sensitivity, beta cell function and cardiovascular markers. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: November 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: 2 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: 3 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Experimental: 4 Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Active Comparator: 5 Drug: Actos
45mg po daily
Placebo Comparator: 6 Drug: Placebo
po daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 PPAR agonist;
  • clinically significant cardiovascular disease;
  • CHF NYHA 3-4.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388518

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85029
Phoenix, Arizona, United States, 85006
United States, California
Beverly Hills, California, United States, 90211
Palm Springs, California, United States, 92262
San Diego, California, United States, 92161
United States, Florida
Chiefland, Florida, United States, 32626
Hollywood, Florida, United States, 33023
West Palm Beach, Florida, United States, 33401
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Baltimore, Maryland, United States, 21229
United States, Mississippi
Olive Branch, Mississippi, United States, 38654
United States, New Jersey
Hamilton, New Jersey, United States, 08610
United States, New York
New Hyde Park, New York, United States, 11042
United States, Tennessee
Johnson City, Tennessee, United States, 37604
United States, Washington
Spokane, Washington, United States, 99216
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, 44650
Guadalajara, Mexico, 44340
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, 129090
Moscow, Russian Federation, 125315
Moscow, Russian Federation, 129327
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 117036
Saratov, Russian Federation, 410038
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197198
Serbia
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00388518     History of Changes
Other Study ID Numbers: BM17864
Study First Received: October 16, 2006
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014