Type 2 Diabetes Mellitus
Conditions
Interventions
Product Name: dual PPAR alpha/gamma agonist
Product Code: Ro 0728804
Pharmaceutical Form: Capsule*
Current Sponsor code: Ro 0728804
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
F.Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18 - 75 years (inclusive) at screening 2.Patients with T2D diagnosed for at least 1 month at screening examination based on WHO criteria 3.Patients with T2D either drug naïve or pre-treated with monotherapy or pre-treated with combination therapy (max. two oral antihyperglycemic medications, neither on maximum dose), at screening 4.HbA1c less than or equal to 10.0 % at screening examination, and 7.0 - 10.0 % (inclusive) at pre-randomization visit 5.FPG > 126 mg/dL (7.0 mmol/L) at screening examination, and less than or equal to 240 mg/dL (13.3 mmol/L) at pre-randomization visit 6. Able and willing to give written informed consent and to comply with the requirements of the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with Type 1 diabetes mellitus 2.History of ketoacidosis 3.Patients with T2D currently or previously treated with insulin (with the exception of emergency cases in which insulin is given for 2 weeks, within 3 months prior to screening examination 8.Impaired liver function (ALAT or ASAT > 2.5x ULN) at screening or pre-randomization examination 9.Impaired renal function (serum creatinine bigger than or equal to 2.0 mg/dL) at screening or pre-randomization examination 10.Anemia defined as hemoglobin 160 mmHg and/or DBP > 100 mmHg despite anti-hypertensive drug therapy) at screening examination 12.Myocardial infarction or stroke within 6 months prior to the screening examination 13.Congestive heart failure classified NYHA class III or IV prior to the screening examination 14.Known proliferative diabetic retinopathy 15.Known hemoglobinopathy 16.Any serious illness (such as metastatic cancer, major active infection, severe psychiatric disorders) at screening 17.Positive pregnancy test, breastfeeding women and women not using an adequate method of contraception 18.Participation in any clinical trial with an investigational drug within three months prior to the screening examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate by a population analysis approach the pharmacokinetics and the exposure-response relationship of RO0728804 in the target patient population. To use the active comparator (Actos®) data to support the dose selection of RO0728804 for comparative Phase 3 studies with model-based simulation, if feasible. ;Main Objective: To determine the dose(s) of RO0728804 which are efficacious in improving glycemic control, safe and tolerable in patients with Type 2 diabetes when administered orally, once daily for 16 weeks as compared to placebo. ;Primary end point(s): EFFICACY: Primary parameter: • HbA1c absolute change from baseline at the end of the treatment period Secondary parameters: • FPG absolute change from baseline at the end of the treatment period • HbA1c response rate defined as percentage of patients with HbA1c decrease from baseline bigger or equal to 0.6 % at the end of the treatment period • HbA1c response rate defined as percentage of patients with HbA1c inferior or equal to 7.0 % at the end of the treatment period (as per the current ADA treatment to target criteria) • Lipid profile [triglycerides, total cholesterol, HDL- and LDL-cholesterol, apoprotein A1 and B, total chol./HDL-chol. ratio, lipoprotein (HDL, LDL, IDL and VLDL) subclass distribution] absolute and percentage change from baseline at the end of the treatment period • Insulin sensitivity and ß cell-function (HOMA-S and HOMA-B) absolute change from baseline at the end of the treatment period • Cardiovascular markers (High sensitive C-reactive protein and adiponectin) absolute change from baseline at the end of the treatment period SAFETY: Adverse events (including edema and hypoglycemia), clinical laboratory tests, ECG, echocardiography, vital signs, physical examination, body weight, waist to hip ratio and hair health questionnaire. PK/PD : Primary PK parameters such as clearance and volume of distribution will be stimated using population pharmacokinetic me | — |
Countries
Greece, Italy
Outcome results
None listed