None listed
Conditions
Interventions
GROUP 1 Type of group
Stabilization period: Duration of 4 weeks. During this period, patients will change their original formulation of Metformin for a generic Metformin of immediate release, in equivalent dose, which will be adjusted according to clinical evaluation. The dose reached will remain until the end of the study.
Treatment period: Duration of 26 weeks. This group will be treated with SYR-322 Placebo, PO, QD + Pioglitazone HCl Placebo PO, QD.
Group name:GROUP 12 Type of group
Stabilization period: Duration of 4 weeks. During this period, patients will change their original formulation of Metformin for a generic Metformin of immediate release, in equivalent dose, which will be adjusted according to clinical evaluation. The dose reached will be maintained until the end of the study.
Treatment period: Duration of 26 weeks. This group will be treated with SYR-322 Placebo, PO, QD + Pioglitazone HCl 45 mg, PO, QD.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Men and women, between 18 and 80 years of age, with a historical diagnosis of type 2 diabetes mellitus who are currently being treated only with metformin, but who do not have adequate glycemic control. 2. A stable dose of metformin ≥ 1500 mg or a DMT at least 2 months before screening. 3. Not be in a treatment with antidiabetic agents other than metformin within 2 months prior to Selection. 4. Body Mass Index ≥ 23 Kg / m2 and ≤ 45 Kg / m2. 5. Fasting C-peptide concentration ≥ 0.8 ng / mL. 6. In the case of other non-excluded medications that are used regularly, they should be at stable doses at least 4 weeks before selection. 7. Systolic blood pressure ≤ 160 mm Hg and diastolic pressure ≤ 100 mm Hg. 8. Hemoglobin ≥ 12 g / dL for men and ≥ 10 g / dL for women. 9. Alanine aminotransferase ≤ 2.5 of the normal upper limit. 10. Serum creatinine <1.5 mg / dL for men and <1.4 mg / dL for women. 11. Thyroid stimulating hormone level ≤ to the upper level of the normal range and the subject must be clinically euthyroid. 12. Not be pregnant or breastfeeding. 13. Women with potential to conceive should use an appropriate contraceptive method. 14. Be able and willing to monitor blood glucose concentrations with a glucose monitor at home. 15. Not having major diseases or weaknesses that prevent the subject from completing the study. 16. Be able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Urine albumin / creatinine ratio> 1000 ug / mg in the Selection. 2. History of cancer. 3. History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Selection. 4. History of diabetic gastroparesis treated. 5. Heart failure classified by the New York Heart Association as Class III or IV regardless of therapy. 6. History of coronary angioplasty, placement of a coronary stent, surgery coronary bypass or myocardial infarction during the 6 months prior to selection. 7. History of any type of hemoglobinopathy that could affect the determination of HbA1c. 8. History of hepatitis B, hepatitis C or human immunodeficiency virus. 9. History of psychiatric disorders that would affect the subject´s ability to participate in the study. 10. History of angioedema related to the use of inhibitors of angiotensin-converting enzyme or angiotensin II receptor inhibitors. 11. History of abuse of alcohol or other substances during the 2 years prior to selection. 12. Have received any medication under investigation within 30 days prior to the selection or history of having received an anti-diabetic medication under investigation during the 3 months prior to the selection. 13. Have received prior treatment in a research study of SYR-322. 14. Hypersensitivity to pioglitazone HCL, SYR-322 or other excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Serum levels in peripheral blood of HbA1C. Measure:Change from baseline HbA1c (Day 1) to Week 26. Timepoints:Week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Peripheral blood measurement of HbA1C levels, fasting glucose, proinsulin, insulin, proinsulin / insulin ratio, C-peptide. Measure:Secondary efficacy: 1) HbA1C. 2) Fasting plasma glucose. 3) Proinsulin. 4) Insulin 5) Proinsulin / insulin ratio. 6) Peptide C. Timepoints:• HbA1C: Weeks 4, 8, 12. 16 and 20. • Glucose fasting: Weeks 1, 2,4, 8, 12, 16, 20 and 26. • Proinsulin, insulin, proportion of proinsulin / insulin, peptide C: Weeks 4, 8. 12, 16, 20 and 26. ; Outcome name:Peripheral blood measurement of serum lipids, free fatty acids, apolipoproteins A1, A2, B and C-III, PAI-1, hsPCR, adiponectin Body weight: Must be measured without shoes and light clothing using a consistent scale. Incidence of marked hyperglycemia: Defined as fasting plasma glucose> 200 mg / dL. Calculation of insulin resistance derived from HOMA-IR and beta cell function derived from HOMA-B Measure:Secondary efficacy: 1) serum lipids. 2) Fractionation of lipids in NMR. 3) Free fatty acids, apolipoprotein A1, A2, B, C-III, PAI-1 and hsPCR. 4) Adiponectin. 5) Body weight. 6) HOMA-IR and HOMA-B. 7) Incidence of marked hyperglycemia. 8) Rescue incident. Timepoints:• Serum Lipids: Weeks 4, 8, 12, 16, 20 and 26. • Fractionation of lipids in NMR: Weeks 12 and 26. • Free fatty acids, apolipoproteins A1, A2, B, C-III, PAI-1, hsPCR, adiponectin: Weeks 12 and 26. • A in Weeks 12 and 26. • Body weight: Weeks 8, 12, 20 and 26. • HOMA-IR and HOMA-B: Weeks 12 and 26. • Incidence of marked hyperglycemia, incidence of rescue: When the event occurs. ; Outcome name:The presence of different levels of HbA1C and the incidence of the change of these will be evaluated: - Incidence of HbA1c ≤ 6.5%. - Incidence of HbA1c ≤ 7.0%. - Incidence of HbA1c ≤ 7.5%. - Incidence of baseline HbA1c change ≥ 0.5%. - Incidence of baseline HbA1c change ≥ 1.0%. - Incidence of baseline HbA1c change | — |
Countries
Australia, Botswana, Bulgaria, Chile, Croatia, Estonia, Guatemala, India, Israel, Latovia, Mexico, New Zealand, Romania, Russian Federation, Serbia, South Africa, Ukraine, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed