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

Hoffmann-La Roche0 sites57 target enrollmentDecember 2012

ConditionsDiabetes Mellitus Type 2

Interventionsaleglitazar placebo metformin

Drugsaleglitazar metformin placebo

Overview

Phase: Phase 2
Intervention: aleglitazar
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 57
Primary Endpoint: Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

September 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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 \</= 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 peroxisome proliferator activated receptor (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

Arms & Interventions

Aleglitazar

Intervention: aleglitazar

Placebo

Intervention: placebo

Aleglitazar

Intervention: metformin

Placebo

Intervention: metformin

Outcomes

Primary Outcomes

Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)

Time Frame: from baseline to Week 16

Secondary Outcomes

Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI)(from baseline to Week 16)
Change in mean 24h blood pressure(from baseline to Week 16)
Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance)(from baseline to Week 16)
Change in parameters of beta cell function (first and second phase insulin secretion)(from baseline to Week 16)
Change in lipid profile(from baseline to Week 16)
Change in fat content/distribution in the abdominal region measured by MRI(from baseline to Week 16)
Change in HbA1c(from baseline to Week 16)
Change in total body fat content measured by air displacement phlethysmography(from baseline to Week 16)
Safety: Incidence of adverse events(22 weeks)
Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS)(from baseline to Week 16)
Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid)(from baseline to Week 16)