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

NCT01691989 | Completed Phase 3

• 1 other identifier: WC28325
• Study Type: interventional
• Target: 197
• Locations: 5 countries
• Sites: 28

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.

Conditions

Diabetes Mellitus Type 2

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 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 markers of insulin sensitivity and cardiovascular risk

  From baseline to week 26

Study Arms (2)

aleglitazar

EXPERIMENTAL

Drug: aleglitazar

placebo

EXPERIMENTAL

Drug: placebo

Interventions

aleglitazar DRUG

150 mcg orally once a day for 26 weeks

aleglitazar

placebo DRUG

oral doses once a day for 26 weeks

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (28)

Unknown Facility

Chino, California, 91710, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

San Diego, California, 92161, United States

Location

Unknown Facility

Santa Ana, California, 92701, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Kissimmee, Florida, 34741, United States

Location

Unknown Facility

St. Petersburg, Florida, 33716, United States

Location

Unknown Facility

Atlanta, Georgia, 30338, United States

Location

Unknown Facility

Avon, Indiana, 46123, United States

Location

Unknown Facility

Bethesda, Maryland, 20817, United States

Location

Unknown Facility

Durham, North Carolina, 27713, United States

Location

Unknown Facility

Morrisville, Pennsylvania, 19067, United States

Location

Unknown Facility

Greer, South Carolina, 29651, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Richmond, Virginia, 23249, United States

Location

Unknown Facility

Buenos Aires, 1056, Argentina

Location

Unknown Facility

Caba, C1428DCO, Argentina

Location

Unknown Facility

Rosario, S2000CXP, Argentina

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Floridablanca, Colombia

Location

Unknown Facility

Medellin-Antioquia, Colombia

Location

Unknown Facility

Guatemala City, 01010, Guatemala

Location

Unknown Facility

Guatemala City, 01014, Guatemala

Location

Unknown Facility

Aguascaliente, 20230, Mexico

Location

Unknown Facility

Celaya, 38000, Mexico

Location

Unknown Facility

Guadalajara, 44600, Mexico

Location

Unknown Facility

Guadalajara, 44650, Mexico

Location

Unknown Facility

Querétaro, 76000, Mexico

Location

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: 25728612 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

ME (5); GU (2); US (15); AR (3); CO (3)