Diabetes Mellitus Type 2
Conditions
Brief summary
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic 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.
Interventions
DRUGPlacebo
oral doses once a day for 26 weeks
DRUGaleglitazar
150 mcg orally once a day for 26 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening * Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past * 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 peroxisome proliferator activated receptor (PPAR) agonist * Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin) * Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in hemoglobin HbA1c | From baseline to week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | From baseline to week 26 |
| Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%) | From baseline to week 26 |
| Change in lipid profile | From baseline to week 26 |
| Change from baseline in homeostatic index of beta cell function (HOMA-BCF) | From baseline to week 26 |
| Safety: incidence of adverse events | 30 weeks (26 weeks treatment and 4 weeks follow-up) |
| Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) | From baseline to week 26 |
Countries
Mexico, United States
Outcome results
None listed