Clinical trial NCT01691989: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy
Official title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERAPY OR WITH SU + METFORMIN COMBINATION 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: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin 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
* Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy 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)
* Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
* 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 markers of insulin sensitivity and cardiovascular risk
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: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Avon
country: United States
state: Indiana
city: Bethesda
country: United States
state: Maryland
city: Durham
country: United States
state: North Carolina
city: Morrisville
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: Rosario
country: Argentina
city: Bogota
country: Colombia
city: Floridablanca
country: Colombia
city: Medellin-Antioquia
country: Colombia
city: Guatemala
country: Guatemala
city: Guatemala
country: Guatemala
city: Aguascaliente
country: Mexico
city: Celaya
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Queretaro
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.