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

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

Overview[ - collapse ][ - ]

Purpose	This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: aleglitazar Drug: placebo Drug: metformin
Phase	Phase 2
Sponsor	Hoffmann-La Roche
Responsible Party	Hoffmann-La Roche
ClinicalTrials.gov Identifier	NCT01729403
First Received	November 14, 2012
Last Updated	April 7, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	November 14, 2012
Last Updated Date	April 7, 2014
Start Date	December 2012
Estimated Primary Completion Date	September 2013
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin
Official Title	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
Brief Summary	This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	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)
Study Arm (s)	Experimental: Aleglitazar Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	57
Estimated Completion Date	September 2013
Estimated Primary Completion Date	September 2013
Eligibility Criteria	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 - Fasting plasma glucose - 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
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01729403
Other Study ID Numbers	WC28038
Has Data Monitoring Committee	Not Provided
Information Provided By	Hoffmann-La Roche
Study Sponsor	Hoffmann-La Roche
Collaborators	Not Provided
Investigators	Study Director: Clinical Trials Hoffmann-La Roche
Verification Date	April 2014

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