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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01691989
First received: September 20, 2012
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  Purpose

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


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
Primary Purpose: Treatment
Official Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERAPY OR WITH SU + METFORMIN COMBINATION THERAPY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • 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 markers of insulin sensitivity and cardiovascular risk [ 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 ]

Enrollment: 197
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aleglitazar Drug: aleglitazar
150 mcg orally once a day for 26 weeks
Experimental: placebo Drug: placebo
oral doses once a day for 26 weeks

  Eligibility

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

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of diabetes mellitus, type 2
  • Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy 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)
  • Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
  • Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691989

  Show 28 Study Locations
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: NCT01691989     History of Changes
Other Study ID Numbers: WC28325
Study First Received: September 20, 2012
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013