A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01729403
First received: November 14, 2012
Last updated: August 4, 2014
Last verified: August 2014

November 14, 2012
August 4, 2014
December 2012
September 2013   (final data collection date for primary outcome measure)
Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate) [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01729403 on ClinicalTrials.gov Archive Site
  • Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance) [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in parameters of beta cell function (first and second phase insulin secretion) [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in HbA1c [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in lipid profile [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in mean 24h blood pressure [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI) [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in fat content/distribution in the abdominal region measured by MRI [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in total body fat content measured by air displacement phlethysmography [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in homeostatic indexes of insulin sensitivity assessed by HOMA-IS [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid) [ Time Frame: from baseline to Week 16 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin
A SINGLE CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II STUDY TO ASSESS THE EFFICACY OF ALEGLITAZAR ON INSULIN SENSITIVITY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2D) WHO ARE INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY

This single-center, randomized, double-blind, placebo-controlled study will eval uate the effect of aleglitazar on insulin sensitivity in patients with type 2 di abetes mellitus who are inadequately controlled on metformin monotherapy. Patien ts will be randomized to receive either aleglitazar 150 mcg or placebo orally da ily for 16 weeks, in addition to their existing dose and regimen of metformin.

Not Provided
Interventional
Phase 2
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, 16 weeks
  • Drug: placebo
    orally daily, 16 weeks
  • Drug: metformin
    patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)
  • Experimental: Aleglitazar
    Interventions:
    • Drug: aleglitazar
    • Drug: metformin
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: placebo
    • Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 30 to 70 years of age inclusive at screening
  • Type 2 diabetes mellitus patients treated with stable metformin therapy for at least 12 weeks prior to screening; metformin dose should not exceed the maximum dose specified in the label
  • HbA1c >/= 6.5% and </= 9% at screening and baseline
  • Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dl) at screening and baseline
  • Body mass index (BMI) >/= 25 at screening; BMI >/= 27 for subjects with HbA1c < 7%
  • Stable weight +/- 5% for at least 12 weeks prior to screening

Exclusion Criteria:

  • Women who are pregnant, 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 type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
  • Any previous treatment with a 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
  • History of bariatric surgery or currently undergoing evaluation for bariatric surgery
  • Prior intolerance to fibrate
  • Treatment with any anti-diabetic medication other than metformin in the last 12 weeks prior to screening and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
  • Clinically apparent liver disease
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Clinical evidence of anemia
  • Symptomatic congestive heart failure (New York Heart Association Class II-IV) at screening
  • Myocardial infarction, acute coronary syndrome, or transient ischemic attack/stroke within 6 months prior to screening
  • Known macular edema at screening or prior to screening visit
  • Uncontrolled hypertension despite stable (for at least 4 weeks) anti-hypertensive treatment
  • Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
  • Chronic oral or parenteral corticosteroid treatment (> 2 weeks) within 3 months prior to screening
  • History of active substance abuse (including alcohol) within the past 2 years or positive test result for drugs of abuse or alcohol prior to first dosing
  • Presence of any absolute or relative contraindication for the conduct of magnetic resonance imaging (MRI) investigation
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01729403
WC28038
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