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
Intervention: Alogliptin; Metformin; Alogliptin Placebo; Metformin Placebo
Intervention description: Alogliptin tablets.; Metformin capsules; Alogliptin placebo-matching tablets.; Metformin placebo-matching capsules.
Intervention MeSH terms: Metformin; Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 784.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes mellitus; Non-insulin dependent diabetes mellitus; Drug Therapy; Hypoglycemia,; Hyperglycemia

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has historical diagnosis of Type 2 Diabetes Mellitus.

          -  Has been treated with diet and exercise for at least 2 months prior to Screening, and
             has a Glycosylated Hemoglobin concentration between 7.5% and 10.0%, inclusive at
             Screening.

          -  Has received less than 7 days of any antidiabetic medication within 2 months prior to
             Screening.

          -  Body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2
             (except for Asian or Asian-descendant subjects for whom the range is between 20 and 35
             kg/ m^2, inclusive).

          -  Fasting C-peptide concentration greater than or equal to 0.8 ng/mL.

          -  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 and males who are sexually active agree to routinely
             use adequate contraception from Screening throughout the duration of the study.

          -  Able and willing to monitor their own blood glucose concentrations with a home glucose
             monitor and complete patient diaries.

        Exclusion Criteria:

          -  Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening
             Visit.

          -  Has a history of any hemoglobinopathy that may affect determination of Glycosylated
             Hemoglobin.

          -  Has a history of laser treatment for proliferative diabetic retinopathy within the 6
             months prior to Screening.

          -  Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric
             bypass surgery.

          -  Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.

          -  Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic
             pressure greater than or equal to 90 mmHg at Screening visit.

          -  Has New York Heart Association Class III to IV heart failure.

          -  Has a history of coronary angioplasty, coronary stent placement, coronary bypass
             surgery, or myocardial infarction within the 90 days prior to Screening.

          -  Has Alanine aminotransferase greater than 3 times the upper limit of normal at
             Screening.

          -  Has a history of alcohol or substance abuse with the 2 years prior to Screening.

          -  Serum creatinine greater than or equal to 1.5 mg/dL for males and greater than or
             equal to 1.4 mg/dL for females.

          -  Has 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.

          -  Has a history of infection with human immunodeficiency virus, hepatitis B virus or
             hepatitis C virus.

          -  Has any major illness or debility that in the investigator's opinion prohibits the
             subject from completing the study.

          -  Has received any investigational drug within the 90 days prior to Screening.

          -  Has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors,
             metformin or related compounds.

          -  Has used oral or systematically injected glucocorticoids or weight loss drugs prior to
             2 months to screening.