Clinical trial NCT01691755: A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in hemoglobin HbA1c
timeFrame: From baseline to week 26
Secondary outcomes:
measure: Change in lipid profile
timeFrame: From baseline to week 26
measure: Change from baseline in fasting plasma glucose
timeFrame: From baseline to week 26
measure: Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)
timeFrame: From baseline to week 26
measure: Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
timeFrame: From baseline to week 26
measure: Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
timeFrame: From baseline to week 26
measure: Safety: incidence of adverse events
timeFrame: 30 weeks (26 weeks treatment and 4 weeks follow-up)
Other outcomes:
Locations:
city: Chino
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Upland
country: United States
state: California
city: West Hills
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Cooper City
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Avon
country: United States
state: Indiana
city: St Peters
country: United States
state: Missouri
city: Greensboro
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Spokane
country: United States
state: Washington
city: Aguascaliente
country: Mexico
city: Cuernavaca
country: Mexico
city: Culiacan
country: Mexico
city: Durango
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Queretaro
country: Mexico
city: Tampico
country: Mexico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.