Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-039-06
• Lead Sponsor: TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Peripheral blood measurement of HbA1C levels.<br>Measure:Change of baseline HbA1C (Day 1) in week 16.<br>Timepoints:Week 16.<br>