Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Alogliptin; Glipizide
Intervention description: Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.; Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
Intervention MeSH terms: Alogliptin; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 441.0
Sex: All
Minimum age: 65 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily
      (QD), compared to glipizide in elderly diabetic patients who have not received treatment or
      are on a single oral medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of type 2 diabetes mellitus with 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.

          -  Females of childbearing potential who are sexually active must agree to use a
             medically accepted means of contraception, and can neither be pregnant nor lactating
             from Screening throughout the duration of the study.

          -  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
             participant 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 for males or less than or equal to 10 g/dL
             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.

          -  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.

          -  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 Human Immunodeficiency Virus.

          -  History of a psychiatric disorder that will affect the participant'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 participant from the study.

          -  Has donated more than 400 mL of blood within the 90 days preceding their participation
             in the study.

          -  Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor
             drug.