None listed
Conditions
Interventions
Group 1 Type of group
Placebo orally in single dose
Group name:Group 7 Type of group
Pioglitazone 45 mg orally in a single daily dose
Sponsors
DAIICHI SANKYO PHARMA DEVELOPMENT,
Eligibility
Inclusion criteria
Inclusion criteria: • Be willing to give written informed consent during the selection. • Diagnosis of type 2 diabetes. • Subjects of male or female sex> 18 years of age. • AlC> 7.0% and <8.5% in the selection. • Subjects currently receiving treatment with a stable dose of an antihyperglycaemic drug other than thiazolidinedione (such as sulfonylureas, meglitinides, insulin secretagogues, metformin, or aglucosidase inhibitors) administered as monotherapy for at least 3 months before the selection. • Subjects without treatment with any antihyperglycemic agent during the 2 months prior to selection. The goal is to enroll at least 20% of subjects without treatment or who have not received prior treatment. • The investigator should consider that subjects who were not treated with an antihyperglycemic agent orally did not have results with the modification of diet and exercise as the only treatment for type 2 diabetes. • The subject must be clinically stable with respect to other medical conditions other than type 2 diabetes. • Concomitant medications (other than oral antihyperglycaemic agents) should be administered in stable doses for at least 30 days prior to enrollment, and no adjustments are expected during the study period.
Exclusion criteria
Exclusion criteria: • History of type 1 diabetes or ketoacidosis. • History of long-term therapy (> 2 months) with insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of A1C levels. The laboratory certification (including expiration date) and the normal reference ranges of all laboratories used during the study must be filed with Daiichi Sankyo Pharma Development before the start of the study. Measure:Change in A1C levels Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:They are analyzed through clinical laboratory evaluations. Measure:Changes in levels of GPA, HOMA indices, Lipid parameters (eg, CT, TG, C-LDL, HDL-C), Apo A-I, Apo B, Adiponectin, Insulin, Peptide C Timepoints:During the study ; Outcome name:They are analyzed through clinical laboratory evaluations. Measure:Changes in Proinsulin, PCR-as, PNC, ProPNC, MMP-9, PAI-1, CD40, 9 IL-6 Timepoints:During the study | — |
Countries
Denmark, Hungary, Lithuania, Peru
Contacts
Public ContactLuis Miguel Franchi
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed