Clinical trial NCT01691846: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plus Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
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: 200
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 plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. 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
* Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
* 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 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 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: Hawaiian Gardens
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: West Hills
country: United States
state: California
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: Bethesda
country: United States
state: Maryland
city: Springfield
country: United States
state: Missouri
city: Toms River
country: United States
state: New Jersey
city: Altoona
country: United States
state: Pennsylvania
city: Beaver
country: United States
state: Pennsylvania
city: Morrisville
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: Rosario
country: Argentina
city: Cuernavaca
country: Mexico
city: Culiacan
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Pachuca
country: Mexico
city: Tampico
country: Mexico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: