None listed
Conditions
Interventions
GROUP 1 Type of group
Period A: All patients in this group will be treated with Placebo, in tablets, PO, QD, for 2 weeks.
Period B: This group will continue with the treatment of Placebo, in tabletting, PO, QD for 26 weeks.
Group name:GROUP 4 Type of group
Period A: All patients in this group will be treated with Placebo, in tablets, PO, QD, for 2 weeks.
Period B: This group will be treated with Pioglitazone, in tablets, at a dose of 45 mg, PO, QD for 26 weeks.
Sponsors
DAIICHI SANKYO PHARMA DEVELOPMENT,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be willing to give written informed consent. 2. Diagnosis of type 2 diabetes. 3. A1C ≥ 7.0% and ≤ 8.5%. 4. Male or female subjects ≥ 18 years of age. 5. Women who are able to conceive (fertile) should use an adequate method of contraception. 6. Peptide C without fasting> 0.5 ng / ml at the time of preselection. 7. Subjects currently receiving treatment with a stable dose of an approved anti-hyperglycemic medication other than thiazolidinedione given as monotherapy for at least 3 months before prescreening and willing to discontinue antihyperglycemic at Visit 2 or for the duration of the prescreening study. O WELL 8. Subjects not currently treated.
Exclusion criteria
Exclusion criteria: 1. History of type 1 diabetes and / or history of ketoacidosis. 2. History of long-term treatment with insulin. 3. History of previous failure of treatment with TZD or intolerance. 4. Treatment with a lipid lowering agent fibrate. 5. Confirmed fasting glucose repetition> 240 mg / dL during the period of pharmacological rest / stabilization and the initial phase with placebo. 6. Body mass index> 45 kg / m2 at the time of pre-selection. 7. History of weight loss> 10% during the 3 months prior to the preselection. 8. Pregnant or nursing woman. 9. SBP ≥ 180 mm Hg and / or DBP ≥ 110 mm Hg. 10. Any known background of ICC. 11. History of unstable angina, myocardial infarction, accident cerebrovascular disease, transient ischemic attack or any revascularization within 6 months prior to the preselection. 12. History of malignancy. 13. Impaired liver function. 14. Evidence of current infectious liver disease. 15. Known infection by human immunodeficiency virus (HIV). 16. Known hemoglobinopathy or chronic anemia requiring specific treatment within 5 years prior to the prescreening visit. 17. History of alcohol or drug abuse within 1 year prior to prescreening. 18. History of unstable major psychiatric disorders. 19. Allergy or hypersensitivity known or suspected to TZD agents. 20. Clinically significant alterations in any analysis prior to randomization. 21. The values ​​of the samples for analysis can not exceed the limits unless approved by the medical monitor and / or the sponsor: 22. Hematuria not explained. 23. Donation of 1 pint (0.5 liters) of blood or more within the previous 30 days. 24. Previous known or possible exposure to rivoglitazone. 25. Contraindication for treatment with 45 mg of pioglitazone per day. 26. Known or suspected allergy, hypersensitivity or intolerance to the excipients of the experimental drug in the study. 27. Participation in a medical intervention, surgical or pharmaceutical study within the previous 30 days. 28. Any condition or concomitant therapy that may pose a risk to the subject or make participation inappropriate for the subject. 29. Direct or family relationship with the sponsor, researcher or staff of the site affiliated with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Serum level of glycosylated hemoglobin (A1C). Measure:Change of A1C, with respect to the baseline data. Timepoints:Week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Serum level of glycosylated hemoglobin (A1C). Criterion 2: Serum glucose level after a fasting period. Criteria 3 and 7: The HOMA indices, which represent insulin and B cell stores, are calculated mathematically, based on serum glucose, insulin, proinsulin and C-peptide levels. Criteria 4 and 5: Serum levels of CT, TG, C-LDL, C-HDL, Apo A-I, and Apo B. Criterion 6: Adiponectin serum levels. Criterion 8: Serum levels of proinsulin, PCR-as, PNC, ProPNC, MMP-9, PAI-1, CD40 and IL-6. Measure:Secondary efficacy: 1) Changes with respect to the baseline values ​​in A1C. 2) Changes with respect to the baseline values ​​in GPA. 3) HOMA indexes. 4) Percentage change with respect to the initial values ​​in the values ​​of the lipid profile. 5) Changes with respect to the baseline values ​​in the CT / C-HDL ratio, C-LDL / C-HDL ratio, and the Apo B / Apo A-1 ratio. 6) Changes with respect to the baseline values ​​in adiponectin. 7) Changes with respect to the baseline values ​​in fasting insulin and C-peptide. 8) Changes with respect to baseline levels in proinsulin, CRP-as, PNC, ProPNC, MMP-9, PAI-1, CD40 and IL-6. Timepoints:Criteria 1 and 2: Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. Criteria 3, 4, 5, 6 and 7: Weeks 12 and 26. Criterion 8: Week 26. ; Outcome name:Criterion 1: Medical evaluation of any unwanted medical event, which occurred to a study subject to whom a pharmaceutical product has been administered and who does not necessarily have a causal relationship with said treatment. Criterion 2: Hematological, chemical and hepatic panels. Criterion 3: Evaluation of heart rate and blood pressure in sitting position. Criterion 4: The physical examination should include minimally clinical evaluations of head, neck, thyroid, eyes, ears, nose, throat, heart, lungs, lymph nodes, abdomen, skin, limbs and musculoskele | — |
Countries
Argentina, Austria, Chile, Czech Republic, Germany, Hungary, India, Latovia, Mexico, Peru, Romania, Serbia, Slovakia, South Africa, Ukraine, United Kindgdom, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed