A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
1 other identifier
interventional
196
2 countries
34
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Nov 2012
Shorter than P25 for phase_3 diabetes-mellitus-type-2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 11, 2016
August 1, 2016
10 months
September 20, 2012
August 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in hemoglobin HbA1c
From baseline to week 26
Secondary Outcomes (6)
Change in lipid profile
From baseline to week 26
Change from baseline in fasting plasma glucose
From baseline to week 26
Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)
From baseline to week 26
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
From baseline to week 26
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
From baseline to week 26
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORaleglitazar
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/=18 years of age
- Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
- Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
- HbA1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose \</=240 mg/dL at pre-randomization visit
- Agreement to maintain diet and exercise habits during the study
You may not qualify if:
- Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
- Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist
- Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
- Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Chino, California, 91710, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Santa Ana, California, 92701, United States
Unknown Facility
Thousand Oaks, California, 91360, United States
Unknown Facility
Upland, California, 91786, United States
Unknown Facility
West Hills, California, 91307, United States
Unknown Facility
Boynton Beach, Florida, 33472, United States
Unknown Facility
Cooper City, Florida, 33024, United States
Unknown Facility
Coral Gables, Florida, 33134, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Atlanta, Georgia, 30338, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Avon, Indiana, 46123, United States
Unknown Facility
City of Saint Peters, Missouri, 63376, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Altoona, Pennsylvania, 16602, United States
Unknown Facility
Scranton, Pennsylvania, 18510, United States
Unknown Facility
Tipton, Pennsylvania, 16684, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Knoxville, Tennessee, 37919, United States
Unknown Facility
Spokane, Washington, 99202, United States
Unknown Facility
Aguascaliente, 20230, Mexico
Unknown Facility
Cuernavaca, 62250, Mexico
Unknown Facility
Culiacán, 80020, Mexico
Unknown Facility
Durango, 34000, Mexico
Unknown Facility
Durango, 34080, Mexico
Unknown Facility
Guadalajara, 44600, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Monterrey, 64460, Mexico
Unknown Facility
Pachuca, 42090, Mexico
Unknown Facility
Querétaro, 76000, Mexico
Unknown Facility
Tampico, 89000, Mexico
Related Publications (1)
Henry RR, Buse JB, Wu H, Durrwell L, Mingrino R, Jaekel K, El Azzouzi B, Andjelkovic M, Herz M. Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials. Diabetes Obes Metab. 2015 Jun;17(6):560-565. doi: 10.1111/dom.12455. Epub 2015 Apr 8.
PMID: 25728612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2012
First Posted
September 25, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 11, 2016
Record last verified: 2016-08