Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined
      with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.
    

Detailed description: 
      There are approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies
      among racial and ethnic populations and has been shown to correlate with age, obesity, family
      history, history of gestational diabetes and physical inactivity. Over the next decade, a
      marked increase in the number of adults with diabetes mellitus is expected.

      Metformin is the usual choice of first-line therapy for type 2 diabetes. Metformin targets
      insulin resistance in type 2 diabetes by inhibiting hepatic glucose production and
      stimulating glucose uptake in skeletal muscle and adipose tissue, which results in a
      long-term glucose-lowering effect.

      Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase-4
      enzyme is thought to be primarily responsible for the in vivo degradation of 2 peptide
      hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and
      glucose-dependent insulinotropic peptide. Both peptides exert important effects on islet beta
      cells to stimulate glucose-dependent insulin secretion as well as regulating beta cell
      proliferation and cytoprotection. Glucagon-like peptide-1, but not glucose-dependent
      insulinotropic peptide, inhibits gastric emptying, glucagon secretion, and food intake.
      Glucose-dependent insulinotropic peptide has been shown to enhance insulin secretion by
      direct interaction with a glucose-dependent insulinotropic peptide -specific receptor on
      islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not
      glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes
      mellitus. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic
      (glucose) control in patients with type 2 diabetes.

      Based on the potential, complimentary mechanisms of action of alogliptin and metformin, this
      study will compare the safety and efficacy of alogliptin and metformin (SYR-322MET) on
      improving glycemic control in patients with type 2 diabetes mellitus who are inadequately
      controlled by diet adjustment and exercise alone.

      Participants taking part in this study will receive dietary and exercise coaching, and will
      monitor their own blood glucose concentrations with a home glucose monitor. Participants will
      also be required to maintain a hypoglycemic diary throughout the course of the study.
      Participation in this study is expected to last up to 34 weeks.
    

Intervention name(s): Alogliptin; Metformin; Alogliptin Placebo; Metformin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Alogliptin tablets.; Metformin capsules; Alogliptin placebo-matching tablets.; Metformin placebo-matching capsules.
Other intervention name(s): SYR-322; Glucophage; Glucophage XR; Riomet; Fortamet; Glumetza; Obimet; Dianben; Diabex; Diaformin
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes mellitus; Non-insulin dependent diabetes mellitus; Drug Therapy; Hypoglycemia,; Hyperglycemia