Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01871428
First received: June 4, 2013
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This multicenter, randomized, double-blind, placebo-controlled study will evalua te 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 o r placebo for 26 weeks.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: aleglitazar
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ITH TYPE 2 DIABETES MELLITUS (T2D) WHO ARE DRUG-NAÏVE TO ANTI-HYPERGLYCEMIC THERAPY

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in lipids [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]
  • Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change in homeostatic index of insulin sensitivity (by HOMA-IS) [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in homeostatic index of beta cell function (by HOMA-BFC) [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in markers of insulin sensitivity/cardiovascular risk [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 30 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: June 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aleglitazar Drug: aleglitazar
150 mcg orally daily
Placebo Comparator: Placebo Drug: placebo
matching aleglitazar placebo orally daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871428

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01871428     History of Changes
Other Study ID Numbers: YC28037
Study First Received: June 4, 2013
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014