None listed
Conditions
Interventions
AVANDIA XR Type of group
AVANDIA XR prolonged-release administration is administered at a dose of 8 mg once a day plus a placebo with the appearance of AVANDIA IR.
Group name:AVANDIA IR Type of group
AVANDIA IR is administered immediate release administered in a dose of 8 mg once a day plus a placebo with the appearance of AVANDIA XR.
Sponsors
GLAXOSMITHKLINE BIOLOGICALS,
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with a clinical diagnosis of type 2 diabetes mellitus according to the ADA. Male or female adults who are between 18 and 75 years of age at the time of selection. Subjects that give their informed consent to participate.
Exclusion criteria
Exclusion criteria: Any clinically significant abnormality identified in the Screening Visit. The use of any investigational drug within 30 days or 5 half-lives (whichever is longer) before administering the first dose of study medication Anemia, defined by a hemoglobin concentration <11 g / dL for men or <10 g / dL for women. The subject has a hemoglobinopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:Change in HbA1c levels from the beginning to the final event with double-blind treatment. Timepoints:24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:Variation with respect to the onset of HbA1c levels measured in weeks 8 and 16 of double-blind treatment. Timepoints:weeks 8 and 16 of treatment | — |
Countries
Peru
Outcome results
None listed