None listed
Conditions
Interventions
GROUP 1 Type of group
Stabilization period: Duration of 4 weeks. All patients will receive Alogliptin Placebo in PO, QD tablets. Period of treatment. Duration of 26 weeks. This group will start with Alogliptin 12.5 mg tablets PO, QD.
Group name:GROUP 3 Type of group
Stabilization period: Duration of 4 weeks. All patients will receive Alogliptin Placebo in PO, QD tablets. Period of treatment. Duration of 26 weeks. This group will continue with Alogliptin Placebo in PO, QD tablets.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Men or women from 18 to 80 years of age, with diabetes mellitus type 2 who are experiencing inadequate glycemic control and who are not receiving antidiabetic treatment at present. 2. Subjects will qualify if any of the following two conditions apply: a) Subjects who have failed diet and exercise treatment. b) Subjects have received <7 days of any antidiabetic therapy in the 3 months prior to selection. 3. Body mass index ≥ 23 kg / m2 and ≤ 45 kg / m2. 4. Fasting C-peptide concentration ≥ 0.8 ng / mL. If this selection criterion is not met, the subject still qualifies if peptide C is ≥ 1.5 ng / mL after an exercise test. 5. Concentration of HbA1C between 7.0% and 10.0%. randomization. 6. The regular use of other medications not excluded, should be based on a stable dose of at least 4 weeks before the selection. 7. Systolic pressure ≤ 180 mmHg and diastolic pressure ≤ 110 mm Hg. 8. Hemoglobin ≥ 12 g / dL for men and ≥ 10 g / dL for women. 9. Alanine aminotransferase ≤ 3 x upper level of normal. 10. Serum creatinine ≤ 2.0 mg/dL. 11. Thyroid stimulating hormone level ≤ the upper limit of the normal range and the subject is clinically euthyroid 12. Not being pregnant, or breastfeeding. 13. Female subjects with a probability of pregnancy should be using contraceptive methods. 14. Capable and with availability to continuously check the blood glucose concentration with a glucometer at home. 15. Not having a serious illness or weakness that prevents the subject from completing the study. 16. Capable and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Albumin / creatinine ratio> 1000 ug / mg at the time of selection. 2. History of cancer, except squamous cells or basal cell carcinoma of the skin, that has not been in complete remission at least 5 years before selection. 3. History of laser treatment for proliferative diabetic retinopathy within 6 months prior to selection. 4. History of diabetic gastric paresis treated. 5. Cardiac insufficiency type III or IV despite therapy. 6. History of coronary angioplasty, coronary stenting, coronary bypass surgery or myocardial infarction during the 6 months prior to selection. 7. History of any type of hemoglobinopathy. 8. History of hepatitis B, hepatitis C or human immunodeficiency virus. 9. History of psychiatric disorders that will affect the subject´s availability to participate in the study. 10. History of angioedema related to the use of inhibitors of angiotensin-converting enzyme or angiotensin receptor inhibitors. 11. History of abuse of alcohol or other substances during the 2 years prior to the selection. 12. Having 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. Having received prior treatment in a research study of SYR-322.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Peripheral blood measurement of HbA1C levels. Measure:Change of baseline HbA1C (Day 1) in week 16. Timepoints:Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Concentration of HbA1C. • Glucose fasting in the Weeks. • Proinsulin. • Insulin. • Proinsulin / insulin ratio. • Peptide C. • Body weight in Weeks 8, 12, 20 and 26. Measure:Secondary efficiency. Timepoints:HbA1C in Weeks 4, 8, 12, 16 and 20. Glucose fasting in Weeks 1, 2,4, 8, 12, 16, 20 and 26. Proinsulin, insulin, proinsulin / insulin ratio and C-peptide in Weeks 4, 8, 12, 16, 20 and 26. Body weight in Weeks 8, 12, 20 and 26. ; Outcome name:Incidence of marked hyperglycemia: Fasting glucose ≥ 200 mg / dL. Rescue incidence: Number of patients that met any of the rescue criteria. Measure:Incidence of marked hyperglycemia. Rescue incident. Timepoints:When the event occurs. ; Outcome name:HbA1C levels that meet the following goals: 1. Incidence of HbA1C ≤6.5% 2. Incidence of HbA1C ≤7.0% 3. Incidence of HbA1C ≤7.5% 4. Incidence of basal change of HbA1C ≥ 1.0%. 5. Incidence of basal change of HbA1C ≥ 1.5%. 6. Incidence of baseline change of HbA1C ≥ 2.0%. Measure:Clinical response. Timepoints:Week 26. ; Outcome name:• Clinical evaluation to determine physical findings, alterations in vital signs, perform a clinical examination of skin and fingers, incidence of adverse events • 12-lead ECG scan. • Incidence of hypoglycemia. • Laboratory evaluations: hematology, serum chemistry and urinalysis. Measure:Safety of the treatment. Timepoints:• Findings of the physical examinations, ECG: Day 1, weeks 12 and 26. • Taking vital signs, laboratory evaluations: Day 1 and weeks 1, 2, 4, 8, 12, 16, 20 and 26. • Perform a clinical examination of skin and fingers, Incidence of adverse events. Day 1 and weeks 1, 2, 4, 8, 12, 16, 20, 26 and 28. • Incidence of hypoglycemia: when the event occurs. ; Outcome name:Analysis of the concentration of SYR-322 in plasma. A total of 2 blood samples will be obtained (one at a lower level and another at a no lower level) for each subject | — |
Countries
Australia, Brazil, Chile, Czech Republic, Dominican Republic, Guatemala, Hungary, India, Mexico, Netherlands, New Zealand, Poland, South Africa, United Kindgdom, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed