Type II Diabetes Mellitus MedDRA version: 14.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 100000004861
Conditions
Interventions
Product Name: Aleglitazar
Product Code: RO0728804
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ALEGLITAZAR
CAS Number: 475479-34-6
Concentration unit: µg microgram(s)
Concentration typ
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patients with type 2 diabetes, 30-70 years of age, treated with stable metformin therapy for at least 12 weeks • HbA1c = 6.5% and = 9% and fasting plasma glucose = 13.3 mmol/L (= 240 mg/dL) • Overweight (BMI = 25) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Type 1 diabetes • Previous treatment with a thiazolidinedione or dual PPAR agonist; prior intolerance to fibrate • Treatment with any anti-diabetes medication other than stable dose metformin within the last 12 week • Treatment any body weight lowering or lipoprotein-modifying therapy (eg, fibrates) within 12 weeks with the exception of statin therapy • History of bariatric surgery • Anaemia • Estimated glomerular filtration rate <60mL/min/1.73m2 • Symptomatic congestive heart failure classified as NYHA class II-IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: To evaluate the effect of aleglitazar on whole body insulin sensitivity compared with placebo after 16 weeks of treatment in patients with T2D inadequately controlled with metformin monotherapy, as assessed by hyperinsulinemic-euglycemic clamp.;Secondary Objective: Efficacy: To evaluate the effect of aleglitazar compared to placebo on hepatic insulin sensitivity, on beta cell function, on parameters of diabetes control, on the lipid profile, on 24-hour blood pressure, on hepatic fat content, on fat distribution and content in the abdominal region, on total body fat content, and on the markers of insulin sensitivity and cardiovascular risk in patients with T2D inadequately controlled with metformin monotherapy Safety: To assess the safety and tolerability of aleglitazar versus placebo, focusing on selected adverse events relevant to PPAR activation or of other interest, cardiovascular events, other adverse events, and serious adverse events;Primary end point(s): • Change in whole-body insulin sensitivity;Timepoint(s) of evaluation of this end point: • 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in liver insulin sensitivity • Change in parameters of beta cell function • Change in parameters of diabetes control (HbA1c, Fasting plasma glucose) • Change in the lipid profile parameters • Change in 24-hour blood pressure • Change in fat content in the liver • Change in fat content and distribution in the abdominal region • Change in markers of insulin sensitivity and cardiovascular risk;Timepoint(s) of evaluation of this end point: • 16 weeks | — |
Countries
Germany
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed