A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety ofAlogliptin Compared to Glipizide in Elderly Subjects with Type 2 Diabetes - SYR-303

• Conditions: Type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-000959-10-HU
• Lead Sponsor: Takeda Global Research & Development Centre (Europe) Limited,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

1. The subject is male or female, between the ages of 65 and 90, inclusive, with a diagnosis of type 2 diabetes mellitus who has either:
a) Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control (defined as an HbA1c concentration between 6.5% and 9.0%, inclusive) while receiving no antidiabetic treatment (defined as less than 7 days of any antidiabetic treatment) within the two months prior to Screening (Study Schedule A). Subjects following Schedule A may be randomized immediately upon confirmation of eligibility.
OR
b) Failed treatment with oral monotherapy alone as demonstrated by inadequate glycemic control (defined as an HbA1c concentration between 6.5% and 8.0%, inclusive) within the two months prior to Screening (Study Schedule B). Subjects following Schedule B will undergo a 4-week washout period including an assessment at the end of washout to re-confirm eligibility prior to randomization (see additional inclusion criteria).
2. Body mass index =23 kg/m2 and =45 kg/m2.
3. Subject is capable of understanding and complying with protocol requirements.
4. Subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
5. If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
6. Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
7. Female subjects of childbearing potential who is sexually active agrees to use adequate contraception (as defined in the informed consent form) from screening throughout the duration of the study.
8. Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
9. No major illness or debility that in the investigator’s opinion prohibits the subject fromcompleting the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Systolic blood pressure =160 mm Hg and/or diastolic pressure =100 mm Hg.
2. Hemoglobin =12 g/dL (=120 gm/L) for males or =10 g/dL (=100 gm/L) for females.
3. Alanine aminotransferase =3 x upper limit of normal.
4. Calculated creatinine clearance =50 mL/min.
5. Thyroid-stimulating hormone level outside of the normal range.
6. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated CIN I or CIN II [cervical intraepithelial neoplasia] is allowed.)
7. History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
8. History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
9. New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study (see Appendix E).
10. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
11. History of any hemoglobinopathy that may affect determination of HbA1c.
12. History of infection with HIV.
13. History of a psychiatric disorder that will affect the subject’s ability to participate in the study.
14. History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
15. History of alcohol or substance abuse within the 2 years prior to Screening.
16. History of treatment with any weight-loss drugs or oral or systemically injected
glucocorticoids within the 3 months prior to Screening.
17. Receipt of any investigational drug within the 30 days prior to Screening.
18. Prior treatment in an investigational study of alogliptin.
19. Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the subject from the study.
20. Subject is a study site employee, or is an immediate family member of a study site employee who is involved in the conduct of this study.
21. Subject has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
22. Subjects who have hypersensitivity or have had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified