Randomized, Double-Blind Active Comparator-Controlled Study of Rivoglitazone in Type 2 Diabetes Mellitus
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsE119Non-insulin-dependent diabetes mellitus, without complications
- Registration Number
- PER-058-07
- Lead Sponsor
- DAIICHI SANKYO PHARMA DEVELOPMENT,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Serum level of glycosylated hemoglobin (A1C).<br>Measure:Change of A1C, with respect to the baseline data.<br>Timepoints:Week 26.<br>
- Secondary Outcome Measures
Name Time Method