A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone

NCT01691846 | Completed Phase 3

• 1 other identifier: BC28035
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 31

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.

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 homeostatic index of beta cell function (HOMA-BCF)

  From baseline to week 26

Study Arms (2)

aleglitazar

EXPERIMENTAL

Drug: aleglitazar+metformin

placebo

PLACEBO COMPARATOR

Drug: placebo+metformin

Interventions

aleglitazar+metformin DRUG

150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)

aleglitazar

placebo+metformin DRUG

Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)

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 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

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)
• Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (31)

Unknown Facility

Chino, California, 91710, United States

Location

Unknown Facility

Hawaiian Gardens, California, 90716, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Santa Ana, California, 92701, United States

Location

Unknown Facility

Thousand Oaks, California, 91360, United States

Location

Unknown Facility

West Hills, California, 91307, United States

Location

Unknown Facility

Kissimmee, Florida, 34741, United States

Location

Unknown Facility

Atlanta, Georgia, 30338, United States

Location

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Chicago, Illinois, 60607, United States

Location

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Avon, Indiana, 46123, United States

Location

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Bethesda, Maryland, 20817, United States

Location

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Springfield, Missouri, 65807, United States

Location

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Toms River, New Jersey, 08753, United States

Location

Unknown Facility

Altoona, Pennsylvania, 16602, United States

Location

Unknown Facility

Beaver, Pennsylvania, 15009, United States

Location

Unknown Facility

Morrisville, Pennsylvania, 19067, United States

Location

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Scranton, Pennsylvania, 18510, United States

Location

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Tipton, Pennsylvania, 16684, United States

Location

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Knoxville, Tennessee, 37919, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

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Richmond, Virginia, 23249, United States

Location

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Spokane, Washington, 99202, United States

Location

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Buenos Aires, 1056, Argentina

Location

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Caba, C1428DCO, Argentina

Location

Unknown Facility

Rosario, S2000CXP, Argentina

Location

Unknown Facility

Cuernavaca, 62250, Mexico

Location

Unknown Facility

Culiacán, 80020, Mexico

Location

Unknown Facility

Guadalajara, 44650, Mexico

Location

Unknown Facility

Mexico City, 11650, Mexico

Location

Unknown Facility

Pachuca, 42060, Mexico

Location

Unknown Facility

Tampico, 89000, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

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
• 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: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (22); ME (6); AR (3)