None listed
Conditions
Interventions
Group 1 Type of group
Aleglitazar 150 mcg po daily for 52 weeks
Group name:Group 2 Type of group
Pioglitazone 45 mg po daily for 52 weeks
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Age> 18 years in the selection visit. • Men and women diagnosed with DM2 based on the WHO criteria for at least 1 month before the selection visit. • 3 Never before receiving the drug or being treated with either monotherapy or a combination therapy of antihyperglycemic drugs (stably for> 1 month in the selection visit, no more than two combined treatments). • HbA1c of 6.5 -10.0% (inclusive) in the selection visit. • Fasting plasma glucose (fasting plasma glucose. FPG) 30 and <60 ml / min / 1.73 m2 in the selection visit • UACR <3000 ug / mg at the visit of choice. • A body mass index from 25.0 kg / m2 (Asian patients; from 23.0 kg / m2) to 35.0 kg / m2. • Be able and willing to provide written informed consent and comply with the requirements of the study protocol
Exclusion criteria
Exclusion criteria: • Previous or current treatment with a thiazolidinedione (eg, medications containing pioglitazone or rosiglitazone such as Actos®, Avandia®, ActoplusMet Avaudamet® or Avandary, another receptor agonist activated by peroxisomal proliferators (peroxisome proliferatoractivated receptor, PPAR) or a PPAR a / y dual agonist, • Previous or current insulin treatment (with the exception of emergency cases in which insulin is administered for 140 mm Hg and / or PAD> 90 mm Hg despite therapy with an antihypertensive drug; mean of two measurements) at the selection visit. • 11. Impaired liver function (TGP or TGO> 3 times above the upper limit of the normal range [upper limit of normal, ULN]) at the selection visit. • Creatine phosphokinase (creatine phosphokinase, CPK)> 3 times on the ULN in the selection visit. • History of drug-induced myopathy. • Hemoglobin <11 g / dl at the selection visit [continuous treatment with erythropoiesis stimulating agents] is allowed. • Congestive heart failure classified as functional class II to IV according to the criteria of the New York Heart Association (NYHA) on or before the selection or randomization visit. • Peripheral edema above the ankle level in the selection or randomization visit. • Myocardial infarction, acute coronary syndrome or transient ischemic stroke / stroke within 6 months prior to selection. • Vascular or cardiac surgery within 6 months prior to the selection visit. • Known macular edema on or before the selection visit. • Major surgery scheduled to be performed during the course of the study. • Any serious illness (such as metastatic cancer. Major active infection, severe psychiatric disorder) at the screening visit. • Any other significant medical condition that does not allow patient participation in this investigative study. • Positive pregnancy test, lactating women and those who are not using an appropriate contraceptive method. • Participation in any clinical study with an investigational drug within three months prior to the selection view.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:In each patient, the individual absolute change from the start with respect to any post-start evaluation is defined as the initial value subtracted from this post-start value. The individual percentage change from the beginning to any post-start evaluation is defined as the value of the individual absolute change divided by the initial value and multiplied by 100. Measure:Percentage change with respect to the initial value of eGFRmdrd at the end of the follow-up period (8 weeks after the end of treatment). Timepoints:8 weeks after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:In each patient, the individual absolute change from the start with respect to any post-start evaluation is defined as the initial value subtracted from this post-start value. The individual percentage change from the beginning to any post-start evaluation is defined as the value of the individual absolute change divided by the initial value and multiplied by 100. Measure:Percentage change with respect to the initial value of eGFRmdrd (after 52 weeks of treatment). Timepoints:after 52 weeks of treatment ; Outcome name:In each patient, the individual absolute change from the start with respect to any post-start evaluation is defined as the initial value subtracted from this post-start value. The individual percentage change from the beginning to any post-start evaluation is defined as the value of the individual absolute change divided by the initial value and multiplied by 100. Measure:Absolute change with respect to the initial value of HbA1c after 52 weeks of treatment. Timepoints:after 52 weeks of treatment | — |
Countries
Australia, Brazil, Colombia, El Salvador, Germany, Hong Kong, Hungaria, Italy, Mexico, Romania, Russian Federation, Slovakia
Contacts
Public ContactPATRICIA MATOS
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed