This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
150 mcg orally daily
matching aleglitazar placebo orally daily
Unnamed facility
Chongqing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shiyan, China
Unnamed facility
Suzhou, China
Unnamed facility
Change in HbA1c
Time frame: from baseline to Week 26
Change in lipids
Time frame: from baseline to Week 26
Change in fasting plasma glucose (FPG)
Time frame: from baseline to Week 26
Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26
Time frame: 26 weeks
Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS])
Time frame: from baseline to Week 26
Change in homeostatic index of beta cell function (by HOMA-BFC)
Time frame: from baseline to Week 26
Change in markers of insulin sensitivity/cardiovascular risk
Time frame: from baseline to Week 26
Safety: Incidence of adverse events
Time frame: approximately 30 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hong Kong, Hong Kong
Unnamed facility
Alor Star, Malaysia
Unnamed facility
Perak, Malaysia