A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01691755
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : August 11, 2016
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 monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: aleglitazar Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 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 Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
oral doses once a day for 26 weeks

Experimental: aleglitazar Drug: aleglitazar
150 mcg orally once a day for 26 weeks

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 A1c (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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
  • Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
  • 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 peroxisome proliferator activated receptor (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 identifier (NCT number): NCT01691755

  Hide Study Locations
United States, California
Chino, California, United States, 91710
Los Angeles, California, United States, 90057
Santa Ana, California, United States, 92701
Thousand Oaks, California, United States, 91360
Upland, California, United States, 91786
West Hills, California, United States, 91307
United States, Florida
Boynton Beach, Florida, United States, 33472
Cooper City, Florida, United States, 33024
Coral Gables, Florida, United States, 33134
Jacksonville, Florida, United States, 32216
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, Missouri
St Peters, Missouri, United States, 63376
United States, North Carolina
Greensboro, North Carolina, United States, 27408
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
Scranton, Pennsylvania, United States, 18510
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Knoxville, Tennessee, United States, 37919
United States, Washington
Spokane, Washington, United States, 99202
Aguascaliente, Mexico, 20230
Cuernavaca, Mexico, 62250
Culiacan, Mexico, 80020
Durango, Mexico, 34000
Durango, Mexico, 34080
Guadalajara, Mexico, 44600
Mexico City, Mexico, 11650
Monterrey, Mexico, 64460
Pachuca, Mexico, 42090
Queretaro, Mexico, 76000
Tampico, Mexico, 89000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01691755     History of Changes
Other Study ID Numbers: BC28034
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

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