None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Alogliptin 12.5 mg in PO QD tablets every day for 26 weeks + Metformin at the established dose in the stabilization period, as a minimum, the dose will be 1500 mg every day for 26 weeks.
Group name:GROUP 3 Type of group
This group will be treated with Alogliptin Placebo in tablets PO QD every day for 26 weeks + Metformin at the established dose in the stabilization period, as a minimum, the dose will be 1500 mg every day 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. Women and men 18 to 80 years of age, with a diagnosis of diabetes mellitus type 2 in their history and who are currently treated with metformin alone but who are experiencing inadequate glycemic control. The subject must have received monotherapy with metformin for at least 3 months prior to selection; In addition, you should have a stable dose ≥1500 mg of metformin for at least 8 weeks prior to randomization. 2. No other antidiabetic treatment except metformin during the 3 months prior to selection, with the exception of those subjects who have received another antidiabetic therapy for less than 7 days within 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%. 6. If another medication that is not excluded is taken regularly, it must be done consistently for at least 4 weeks before 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 <1.5 mg / dL for men and <1.4 mg / dL for women. 11. The level of the thyroid stimulating hormone below or equal to the upper limit of normal levels, and clinically the subject has euthyroidism. 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 26. Timepoints:Week 26. | — |
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 | — |
Countries
Czech Republic, Germany, Hungary, Peru, Spain, United Kindgdom
Outcome results
None listed