Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Type 2 diabetes is among the most common chronic condition in adults 65 years of age or
      older. A recent National Health and Nutrition Examination Survey reported that more than 20%
      of adults aged 65 years or older have diabetes. These individuals are often under-treated
      with respect to glucose-lowering medications, and their care is complicated by the extent of
      their clinical and functional status. Age-related changes in physiology, diabetes-associated
      illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as
      use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use
      problematic. In addition, hypoglycemia is more common and severe in older rather than younger
      patients taking oral antidiabetic drugs which can precipitate serious events such as falls
      and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients,
      many commonly used medications are associated with a substantial risk for hypoglycemia. New
      classes of drug which avoid such complications in the elderly population are of increasing
      interest as this population continues to expand.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of
      2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2
      diabetes.

      This study will compare the effectiveness and safety of alogliptin with that of glipizide (a
      commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2
      diabetes. Individuals who participate in this study will either have failed diet and exercise
      therapy alone during the 2 months before Screening, or will have been receiving a single oral
      antidiabetic medication without obtaining good blood glucose (sugar) control.

      Each participant will be required to commit to screening visits. Study participation is
      anticipated to be up to 59 weeks.
    

Intervention name(s): Alogliptin; Glipizide
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): SYR110322; SYR-322; Glucotrol
Intervention MeSH terms: Alogliptin; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy