A Study of Aleglitazar in Patients With Type 2 Diabetes

NCT00388518 | Completed Phase 2

• 1 other identifier: BM17864
• Study Type: interventional
• Target: 332
• Locations: 8 countries
• Sites: 55

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in Hemoglobin A1c (HbA1c)

  16 weeks

Secondary Outcomes (2)

• Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.

  16 weeks

• Adverse Events (AEs), laboratory parameters.

  Throughout study

Study Arms (6)

Actos

ACTIVE COMPARATOR

Drug: Actos

Aleglitazar 1

EXPERIMENTAL

Drug: aleglitazar

Aleglitazar 2

EXPERIMENTAL

Drug: aleglitazar

Aleglitazar 3

EXPERIMENTAL

Drug: aleglitazar

Aleglitazar 4

EXPERIMENTAL

Drug: aleglitazar

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Actos DRUG

45mg po daily

Actos

Placebo DRUG

po daily

Placebo

aleglitazar DRUG

Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.

Aleglitazar 1; Aleglitazar 2; Aleglitazar 3; Aleglitazar 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (55)

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

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Phoenix, Arizona, 85029, United States

Location

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Beverly Hills, California, 90211, United States

Location

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Palm Springs, California, 92262, United States

Location

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San Diego, California, 92161, United States

Location

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Chiefland, Florida, 32626, United States

Location

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Hollywood, Florida, 33023, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Augusta, Georgia, 30909, United States

Location

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Idaho Falls, Idaho, 83404, United States

Location

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Chicago, Illinois, 60611, United States

Location

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Baton Rouge, Louisiana, 70809, United States

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Baltimore, Maryland, 21229, United States

Location

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Olive Branch, Mississippi, 38654, United States

Location

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Hamilton, New Jersey, 08610, United States

Location

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New Hyde Park, New York, 11042, United States

Location

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Johnson City, Tennessee, 37604, United States

Location

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Spokane, Washington, 99216, United States

Location

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Athens, 12462, Greece

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Thessaloniki, 56429, Greece

Location

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Hong Kong, Hong Kong

Location

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Bologna, 40138, Italy

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Genova, 16132, Italy

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Napoli, 80100, Italy

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Olbia, 07026, Italy

Location

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Pavia, 27100, Italy

Location

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Perugia, 06126, Italy

Location

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Roma, 00133, Italy

Location

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Siena, 53100, Italy

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Torino, 10126, Italy

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Aguascalientes, 20230, Mexico

Location

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Chihuahua City, 31238, Mexico

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Cuernavaca, 62250, Mexico

Location

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Durango, 34080, Mexico

Location

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Guadalajara, 44340, Mexico

Location

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Guadalajara, 44650, Mexico

Location

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Mexico City, 10700, Mexico

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Monterrey, 66260, Mexico

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Pachuca, 42086, Mexico

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Bucharest, 020475, Romania

Location

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Bucharest, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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Galati, 800352, Romania

Location

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Ploieşti, 100163, Romania

Location

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Moscow, 117036, Russia

Location

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Moscow, 125315, Russia

Location

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Moscow, 129090, Russia

Location

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Moscow, 129110, Russia

Location

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Moscow, 129327, Russia

Location

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Saint Petersburg, 197089, Russia

Location

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Saint Petersburg, 197198, Russia

Location

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Saratov, 410038, Russia

Location

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Belgrade, 11000, Serbia

Location

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Kragujevac, 34000, Serbia

Location

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Niš, 18000, Serbia

Location

Related Publications (1)

• Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.

  PMID: 19515415 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; aleglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

SE (3); IT (9); HK (1); RO (5); RU (8); US (18); GR (2); ME (9)