A Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: 25 mg alogliptin + glipizide placebo (Drug); alogliptin placebo + 5 mg or 10 mg glipizide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
VP Biological Sciences, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.

Overall contact:
Study Manager, Phone: 910-251-0081

This is an efficacy and safety study comparing alogliptin and glipizide in elderly diabetic patients that have not received treatment or are on an oral monotherapy.

Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Glycosylated hemoglobin change from baseline

Secondary outcome:

Glycosylated hemoglobin measurement

Incidence of hypoglycemia

Incidence of marked hyperglycemia (fasting plasma glucose ≥200 mg/dL).

Fasting plasma glucose

2-hour postprandial glucose

Proinsulin

Insulin

Proinsulin/insulin ratio

Homeostasis model assessment-B-cell function

Body weight

Serum lipids

High sensitivity C-reactive protein testing

Clinical response endpoint incidence of glycosylated hemoglobin measurement 6.5%

Clinical response endpoint incidence of glycosylated hemoglobin measurement 7.0%

Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline 0.5%

Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline 1.0%

Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline 1.5%

Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline 2.0%

Quality of Life scale scores and Pharmacoeconomic Outcomes measures

Detailed description: Subjects participating in this study will be assigned to one of two treatment groups and receive either 25 mg of alogliptin or 5 mg to 10 mg of glipizide once daily for 52 weeks.

Subjects are required to make weekly visits throughout the course of the study. Total duration of this study is 54 weeks.

Minimum age: 65 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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:

- Failed diet and exercise therapy alone as demonstrated by inadequate glycemic

control while receiving no antidiabetic treatment within the two months prior to Screening, or

- Failed treatment with oral monotherapy alone (may include treatment with two or

more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.

- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.

- 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.

- Female subject of childbearing potential who is sexually active agrees to use adequate

contraception from screening throughout the duration of the study, and can neither pregnant nor lactating.

- Able and willing to monitor their own blood glucose concentrations with a home glucose

monitor.

- No major illness or debility that in the investigator's opinion prohibits the subject

from completing the study.

Exclusion Criteria:

- Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure

greater than or equal to 100 mm Hg.

- Hemoglobin less than or equal to 12 g/dL (less than or equal to 120 gm/L) for males or

less than or equal to 10 g/dL (less than or equal to 100 gm/L) for females.

- Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.

- Calculated creatinine clearance less than or equal to 50 mL/min.

- Thyroid-stimulating hormone level outside of the normal range.

- 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.)

- History of laser treatment for proliferative diabetic retinopathy within the 6 months

prior to Screening.

- History of treated diabetic gastroparesis, gastric banding, or gastric bypass

surgery.

- 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).

- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or

myocardial infarction within the 6 months prior to Screening.

- History of any hemoglobinopathy that may affect determination of glycosylated

hemoglobin.

- History of infection with HIV.

- History of a psychiatric disorder that will affect the subject's ability to

participate in the study.

- History of angioedema in association with use of angiotensin-converting enzyme

inhibitors or angiotensin-II receptor inhibitors.

- History of alcohol or substance abuse within the 2 years prior to Screening.

- History of treatment with any weight-loss drugs or oral or systemically injected

glucocorticoids within the 3 months prior to Screening.

- Receipt of any investigational drug within the 30 days prior to Screening.

- Prior treatment in an investigational study of alogliptin.

- 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.

- Subject has donated more than 400 mL of blood within the 90 days preceding their

participation in the study.

- Subjects who have hypersensitivity or have had an anaphylactic reaction(s) to any

DPP-4 inhibitor drug.

Study Manager, Phone: 910-251-0081

Alexander City, Alabama, United States; Recruiting

Anaheim, California, United States; Recruiting

Foothill Ranch, California, United States; Recruiting

Huntington Park, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Redlands, California, United States; Recruiting

San Dimas, California, United States; Recruiting

Prospect, Connecticut, United States; Recruiting

Bradenton, Florida, United States; Recruiting

Fort Myers, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Ormond Beach, Florida, United States; Recruiting

Roswell, Georgia, United States; Recruiting

Aurora, Illinois, United States; Recruiting

South Bend, Indiana, United States; Recruiting

Salisbury, Maryland, United States; Recruiting

Clarkston, Michigan, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Hamilton, New Jersey, United States; Recruiting

Beachwood, Ohio, United States; Recruiting

Westlake, Ohio, United States; Recruiting

Zanesville, Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Bensalem, Pennsylvania, United States; Recruiting

Aiken, South Carolina, United States; Recruiting

Greenville, South Carolina, United States; Recruiting

Taylors, South Carolina, United States; Recruiting

Corpus Christi, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

Pasadena, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Tomball, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Starting date: June 2008
Ending date: June 2010
Last updated: October 20, 2008