A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to 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: NCT01871428
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Doubleblind, 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 Antihyperglycemic Therapy
Study Start Date : June 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aleglitazar Drug: aleglitazar
150 mcg orally daily

Placebo Comparator: Placebo Drug: placebo
matching aleglitazar placebo orally daily

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

Secondary Outcome Measures :
  1. Change in lipids [ Time Frame: from baseline to Week 26 ]
  2. Change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 26 ]
  3. Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26 [ Time Frame: 26 weeks ]
  4. Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS]) [ Time Frame: from baseline to Week 26 ]
  5. Change in homeostatic index of beta cell function (by HOMA-BFC) [ Time Frame: from baseline to Week 26 ]
  6. Change in markers of insulin sensitivity/cardiovascular risk [ Time Frame: from baseline to Week 26 ]
  7. Safety: Incidence of adverse events [ Time Frame: approximately 30 weeks ]

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 patient, >/= 18 years of age
  • Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening
  • Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time 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 </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
  • Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study

Exclusion Criteria:

  • Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
  • Diagnosis or history of:

    1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
    2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
  • Any previous treatment with thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
  • Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy
  • Prior intolerance to fibrate
  • Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening
  • Clinically apparent liver disease
  • Anemia at or within 4 weeks prior to screening
  • Inadequate renal function
  • Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening
  • Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
  • Known macular edema at screening or prior to screening visit
  • Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
  • Uncontrolled hypertension
  • History of active substance abuse (including alcohol) within the past 2 years

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): NCT01871428

Chongqing, China, 400016
Shanghai, China, 200003
Shiyan, China, 442000
Suzhou, China, 215004
Hong Kong
Hong Kong, Hong Kong
Alor Setar, Malaysia, 05400
Perak, Malaysia, 33400
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01871428     History of Changes
Other Study ID Numbers: YC28037
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases