None listed
Conditions
Interventions
This group will be treated with GW677954 2.5 mg QD PO for 16 weeks. Patients may continue their usual metformin monotherapy.
Group name:ARM 7 Type of group
This group will be treated with Pioglitazone 30 mg QD PO for 4 weeks and the dose will be increased to 45 mg QD PO until 16 weeks. Patients may continue their usual metformin monotherapy.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with T2DM. 2. To be eligible for Randomization in the study, a subject must meet all of the following glycemic criteria: a) HbA1c level via the central laboratory in the pre-selection visit. b) If HbA1c is> 8.0% but 7.8% but 25 and <40 kg / m2 and weigh at least 50 kg in the Selection. 7. If the subject is a smoker, he should be able to abstain while in the clinic at each visit. 8. Subjects provided full written informed consent before any procedure related to the study was performed.
Exclusion criteria
Exclusion criteria: 1. Metabolic disease. 2. Previous use of insulin for the treatment of hyperglycemia within 3 months of the Selection. 3. History of a recent clinically significant cardiovascular disease. 4. History of chronic pancreatitis. 5. Familial hypercholesterolemia. 6. TGs> 800 mg / dL (8.96 mmol / L) in the Selection. 7. Serum creatinine in the selection> 1.4 mg / dL (124 pmol / L) for women, or> 1.5 mg / dL (133 pmol / L) for men. 8. Clinically significant anemia. 9. History of significant co-morbid diseases. 10. Documented history of hepato-biliary disease. 11. History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates. 12. Any subject who withdrew from therapy due to AEs after taking PPARy or a dual PPAR agonist and / or marketed. 13. Signs or symptoms of myositis in the Selection. 14. Who is currently taking or has taken any of the following medications 3 months before the pre-selection visit: a) Anti-obesity agents b) St, John´s Wort c) Warfarin and gold anticoagulants d) Digoxin e) Oral or injectable corticosteroids f) Antidiabetic agents (apart from metformin) g) TZDs 3 months before the pre-selection visit. h) Methotrexate, cyclosporine or monoclonal antibodies i) Atypical antipsychotic drugs j) Antiretroviral drugs k) Lipid reducing agents within 3 months prior to the pre-selection visit. l) Monoamine oxidase inhibitors 15. History of cancer. 16. Women who are breastfeeding, pregnant or who plan to become pregnant. 17. Idiosyncrasy or known immediate or delayed reaction of hypersensitivity to any drug chemically related to the study drug. 18. Known allergy to any of the excipients of the capsule, and history of allergies to the drug or other allergies that contradict participation. 19. Presents a history of abuse of a substance and / or alcohol within the last year. 20. He received treatment with a new molecular entity in the 4 months prior or participated in any other study during the previous 3 months, or has participated in a previous study with GW677954. 21. Likely to not comply with the protocol or scheduled visits. 22. The subject presents any concomitant medical condition that makes it unsuitable for participating in the study. 23. The subject is a close member of the family of a participating researcher, study coordinator, employee of an investigator; or a staff member who conducts the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Glycosylated hemoglobin (HbA1c). Measure:Primary Efficacy: Glycemic control. Timepoints:Day 1 and weeks 4, 6, 8, 12 and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting glucose (FPG). Fructosamine Proportion of subjects who reached target HbA1c levels. Proportion of subjects who reached target levels of FPG. Measure:Secondary Efficacy: Glycemic control. Timepoints:FPG: Day 1 and weeks 1, 2, 4, 5, 8, 12 and 16. HbA1c: Day 1 and weeks 4, 6, 8, 12 and 16. Fructosamine: Day 1 and weeks 2 and 4. ; Outcome name:Lipid profile: TC, HDL-C, LDL-C. Tgs, free fatty acids (FFA). Other lipid markers: VLDL-C, apo AI, AII and B. Measure:Secondary Efficacy: Lipid control. Timepoints:Lipid profile: Day 1 and weeks 2, 4, 8, 12 and 16. Other lipid markers: Day 1 and week 16. ; Outcome name:Insulin and C-peptide levels:Homeostasis model assessment- insulin sensitivity (HOMA-S) andQuantitative Insulin Sensitivity Check Index (QUICKI). Measure:Pharmacodynamics Timepoints:Day 1 and week 16. | — |
Countries
Argentina, Australia, Canada, Colombia, Costa Rica, Czech Republic, Ecuador, Latovia, Mexico, Russian Federation, United States
Outcome results
None listed