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A Study of Aleglitazar in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00388518
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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 Peroxisome Proliferator Activated Receptor (PPAR) agonist;
  • clinically significant cardiovascular disease;
  • Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00388518


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00388518    
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases