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: August 4, 2014
Last verified: August 2014

June 4, 2013
August 4, 2014
June 2013
November 2013   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: from baseline to Week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01871428 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: aleglitazar
    150 mcg orally daily
  • Drug: placebo
    matching aleglitazar placebo orally daily
  • Experimental: Aleglitazar
    Intervention: Drug: aleglitazar
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Malaysia
 
NCT01871428
YC28037
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP