A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01691846
First received: September 20, 2012
Last updated: April 7, 2014
Last verified: April 2014

September 20, 2012
April 7, 2014
October 2012
September 2013   (final data collection date for primary outcome measure)
Change from baseline in hemoglobin HbA1c [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01691846 on ClinicalTrials.gov Archive Site
  • Change in lipid profile [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
  • Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%) [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in homeostatic index of beta cell function (HOMA-BCF) [ Time Frame: From baseline to week 26 ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 30 weeks (26 weeks treatment and 4 weeks follow-up) ] [ 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 Alone
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 T2D INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. 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.

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 once a day for 26 weeks
  • Drug: placebo
    oral doses once a day for 26 weeks
  • 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
200
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of diabetes mellitus type 2
  • Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
  • 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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Mexico
 
NCT01691846
BC28035
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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