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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 Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01871415
First received: June 4, 2013
Last updated: November 10, 2014
Last verified: November 2014

June 4, 2013
November 10, 2014
May 2013
August 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 NCT01871415 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 Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy
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 TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY

This multicenter, randomized, double-blind, placebo-controlled study will evalua te the efficacy, safety and tolerability of aleglitazar in combination with metf ormin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive either alegli tazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre

-existing metformin regimen and dose.

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: metformin
    pre-existing background regimen and dose
  • Drug: placebo
    matching aleglitazar placebo orally daily
  • Experimental: Aleglitazar + metformin
    Interventions:
    • Drug: aleglitazar
    • Drug: metformin
  • Active Comparator: Placebo + metformin
    Interventions:
    • Drug: metformin
    • 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
7
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patient, >/= 18 years of age
  • Type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be >/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label
  • 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
  • Treatment with anti-diabetic medication other than metformin in the last 12 weeks prior to screening
  • 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,   Korea, Republic of
 
NCT01871415
YC28036
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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