None listed
Conditions
Interventions
ARM1 Type of group
This group will be treated with SYR-322, in tablets, at a dose of 12.5 mg, PO, QD + Pioglitazone, in tablets, at a dose of 30 mg, PO, QD. This scheme will be administered for 26 weeks.
Group name:GROUP 4 Type of group
This group will be treated with SYR-322 Placebo, in tablets, PO, QD + Pioglitazone, in tablets, at a dose of 30 mg, PO, QD. This scheme will be administered for 26 weeks.
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. 2. Treatment with diet and exercise of the subject has failed, at least 2 months prior to the Evaluation for Selection. 3. The subject experiences inadequate glycemic control, defined as HbA1c concentrations between 7.5-11%. 4. The subject has received less than 7 days of any antidiabetic therapy within 3 months prior to the Evaluation for Selection. 5. The subject is able to understand and meet the requirements of the protocol. 6. The subject or the legal representative of the subject signs a written informed consent form before initiating any of the study procedures. 7. The subject has a Body Mass Index ≥ 23 kg / m2 and ≤ 45 kg / m2. 8. The subject has a fasting C-peptide ≥ 0.8 ng / mL (0.26 nmol / L). 9. The subject who has regularly used other medications not excluded, must be with a stable dose at least 4 weeks before the Evaluation for Selection. 10. Women of childbearing age should use an adequate contraceptive method from the Evaluation for Selection and throughout the study. 11. The subject is not pregnant or nursing. 12. The subject should be able and willing to monitor their blood concentrations with a glucose monitor at home.
Exclusion criteria
Exclusion criteria: 1. The subject has a systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg. 2. The subject has hemoglobin ≤ 12 g / dL for men and ≤ 10 g / dL for women. 3. Subject has alanine aminotransferase (ALT)> 2.5x upper normal limit. 4. Subject has serum creatinine> 2.0 mg / dL. 5. The subject has a level of thyroid stimulating hormone> at the upper limit of normal. 6. The subject has a major illness or weakness that prevents the subject from completing the study. 7. The subject has a urine albumin / creatinine ratio> 1000 pg / mg in the evaluation for the Selection. 8. The subject has a history of cancer. 9. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to the evaluation for the Selection. 10. The subject has a history of gastroparesis. 11. The subject has heart failure classified as class III or IV. 12. Subject has a history of coronary angioplasty, coronary stenting, coronary bypass surgery, or myocardial infarction within 6 months prior to screening. 13. The subject has a history of any type of hemoglobinopathy that could affect the determination of HbA1c. 14. The subject has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 15. The subject has a history of psychiatric disorders that will affect their availability to participate in the study. 16. The subject has a history of angioedema related to the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor inhibitors. 17. The subject has had any alteration of angiotensin II receptor inhibitors during the 2 months prior to randomization. 18. The subject has a history of alcohol abuse or substance abuse within 2 years prior to the Screening Evaluation. 19. The subject has received any investigational medication within 30 days prior to the evaluation for the selection or history of having received an anti-diabetic medication under investigation during the 3 months prior to the Screening Evaluation. 20. The subject has previously participated in a research study of SYR-322. 21. Subject is unable to understand oral or written English or any other language for which a certified translation of the approved informed consent is available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Serum levels of glycosylated hemoglobin (HbA1c). Measure:Change, with respect to the baseline, of HbA1c (Day 1) in week 26. Timepoints:Week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1-7: Serum levels of glycosylated hemoglobin (Hb1Ac), fasting glucose, proinsulin, insulin, C-peptide, serum lipids (total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides), fatty acids free, apolipoproiein A1, A2, B, C-III, PAI-1, hsCRP, adiponectin Measure:Secondary efficacy: 1) HbA1c levels. 2) Fasting plasma glucose. 3) Proinsulin. 4) Insulin 5) Proinsulin / insulin ratio. 6) Peptide C. 7) Serum lipids. Timepoints:1) HbA1c: Weeks 4, 8, 12, 16 and 20. 2) Glucose fasting: Weeks 1, 2, 4, 8, 12, 16, 20 and 26. 3) Proinsulin, insulin, C peptide, insulin / proinsulin ratio, serum lipids: Weeks 4, 8, 12, 16, 20 and 26. ; Outcome name:Criterion 8: Fractionation of lipids by means of nuclear magnetic resonance. Criteria 9, 10: Serum levels of glycosylated hemoglobin (Hb1Ac), fasting glucose, proinsulin, insulin, C-peptide, serum lipids (total cholesterol, high-density lipoproteins, low-density lipoproteins and triglycerides), free fatty acids, apolipoproiein A1 , A2, B, C-III, PAI-1, hsCRP, adiponectin. Measure:Secondary efficacy: 8) Fractionation of NMR lipids. 9) Free fatty acids, apolipoproiein A1, A2, B, C-III, PAI-1, and hsCRP. 10) Adiponectin. Timepoints:1) Fractionation of lipids of NMR, free fatty acids, apolipoproiein A1, A2, B, C-III, PAI-1, hsCRP, adiponectin: Weeks 12 and 26 ; Outcome name:Criterion 11: The weight should be measured without shoes and light clothing using a consistent scale and in kilograms. Criterion 12: Derivatives of the HOMA equation calculated on the basis of the levels of insulin, proinsulin, C-peptide and glucose. Criterion 13: Fasting plasma glucose levels ≥ 200 mg / dL (11.K mmol / L). Criterion 14: Clinical evaluation of fasting glucose, which are above the rescue criteria for weeks 4, 8, 12 and until the final visit. Measure:Secondary efficacy: 11) Body weight. 12) Insulin resistance and beta cell function. 13) Inc | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Chile, Croatia, Estonia, Guatemala, Hungary, India, Israel, Latovia, Lithuania, Mexico, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Ukraine, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed