A Study of Aleglitazar in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388518
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Actos Drug: Placebo Drug: aleglitazar Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Placebo Comparator: Placebo Drug: Placebo
po daily

Primary Outcome Measures :
  1. Absolute change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 16 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388518

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85029
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
Athens, Greece, 12462
Thessaloniki, Greece, 56429
Hong Kong
Hong Kong, Hong Kong
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
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
Bucharest, Romania, 020475
Bucharest, Romania
Cluj-napoca, Romania, 400006
Galati, Romania, 800352
Ploiesti, Romania, 100163
Russian Federation
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 125315
Moscow, Russian Federation, 129090
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 129327
Saratov, Russian Federation, 410038
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197198
Belgrade, Serbia, 11000
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00388518     History of Changes
Other Study ID Numbers: BM17864
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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