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

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ClinicalTrials.gov Identifier: NCT01691846
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: aleglitazar+metformin Drug: placebo+metformin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: aleglitazar Drug: aleglitazar+metformin
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)
Placebo Comparator: placebo Drug: placebo+metformin
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)

Primary Outcome Measures :
  1. Change from baseline in hemoglobin HbA1c [ Time Frame: From baseline to week 26 ]

Secondary Outcome Measures :
  1. Change in lipid profile [ Time Frame: From baseline to week 26 ]
  2. Change from baseline in fasting plasma glucose [ Time Frame: From baseline to week 26 ]
  3. Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%) [ Time Frame: From baseline to week 26 ]
  4. Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) [ Time Frame: From baseline to week 26 ]
  5. Change from baseline in homeostatic index of beta cell function (HOMA-BCF) [ Time Frame: From baseline to week 26 ]
  6. Safety: incidence of adverse events [ Time Frame: 30 weeks (26 weeks treatment and 4 weeks follow-up) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691846

  Hide Study Locations
United States, California
Chino, California, United States, 91710
Hawaiian Gardens, California, United States, 90716
Los Angeles, California, United States, 90057
Santa Ana, California, United States, 92701
Thousand Oaks, California, United States, 91360
West Hills, California, United States, 91307
United States, Florida
Kissimmee, Florida, United States, 34741
United States, Georgia
Atlanta, Georgia, United States, 30338
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Indiana
Avon, Indiana, United States, 46123
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Missouri
Springfield, Missouri, United States, 65807
United States, New Jersey
Toms River, New Jersey, United States, 08753
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
Beaver, Pennsylvania, United States, 15009
Morrisville, Pennsylvania, United States, 19067
Scranton, Pennsylvania, United States, 18510
Tipton, Pennsylvania, United States, 16684
United States, Tennessee
Knoxville, Tennessee, United States, 37919
United States, Texas
Dallas, Texas, United States, 75230
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Spokane, Washington, United States, 99202
Buenos Aires, Argentina, 1056
Caba, Argentina, C1428DCO
Rosario, Argentina, S2000CXP
Cuernavaca, Mexico, 62250
Culiacan, Mexico, 80020
Guadalajara, Mexico, 44650
Mexico City, Mexico, 11650
Pachuca, Mexico, 42060
Tampico, Mexico, 89000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01691846     History of Changes
Other Study ID Numbers: BC28035
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs