Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Alogliptin; Alogliptin; Alogliptin; Alogliptin; Alogliptin; Placebo
Intervention description: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks; Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Intervention MeSH terms: Alogliptin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Drug Therapy; Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Hyperinsulinism; Insulin Resistance

Summary:

      The purpose of this study is to determine the safety and efficacy of alogliptin, once daily
      (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of
      sulfonylurea and metformin for treating subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus and were either receiving no current treatment or
             currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea
             and metformin but experiencing inadequate glycemic control. Subjects qualified as
             receiving no current treatment if 1 of the following conditions applied:

               -  Subject was newly diagnosed (ie, had not received any treatment).

               -  Subject was treated with diet and exercise alone for the 3 months prior to
                  Screening

               -  Subject had received <7 continuous days of any antidiabetic therapy within the 3
                  months prior to Screening.

               -  Subject had a diagnosis of type 2 diabetes mellitus based on current American
                  Diabetes Association criteria: fasting plasma glucose ≥126 mg/dL, oral glucose
                  tolerance test at 2 hours after administration of the glucose load must have been
                  ≥200 mg/dL, or symptoms of diabetes plus casual plasma glucose ≥200 mg/dL.

          -  Body mass index ≥23 kg/m2 and ≤40 kg/m2.

          -  Fasting C-peptide concentration ≥0.8 ng/mL.

          -  Glycosylated hemoglobin concentration between 6.8% and 11.0%.

          -  Fasting plasma glucose >126 mg/dL at Screening.

          -  No treatment within the 3 months prior to Screening with any other agents known to
             have effects on glucose (other than as described above, a sulfonylurea, metformin, or
             a combination of a sulfonylurea and metformin in subjects on antidiabetics), including
             but not limited to the following:

               -  Other antidiabetic agents

               -  Investigational antidiabetic agents

               -  Niacin

               -  Regular use of systemic glucocorticoids.

               -  No treatment within the 3 months prior to Screening with weight-loss drugs

               -  If taking other non-excluded medications, must have been on a stable dose of
                  medication for at least 4 weeks.

          -  Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg.

          -  Female subjects could neither be pregnant (confirmed by laboratory testing) nor
             lactating, and if of childbearing potential must have been practicing adequate
             contraception.

          -  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 prohibited the subject
             from completing the study.

          -  Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females.

          -  Hepatic transaminase ≤2 x upper limit of normal.

        Exclusion Criteria:

          -  History of cancer, other than squamous cell or basal cell carcinoma of the skin, that
             had not been in full remission for at least 1 year prior to Screening.

          -  History of proteinuria >1000 mg/day on a 12- or 24-hour urine collection OR a urine
             albumin/creatinine ratio >1000 μg/mg at Screening. If elevated, the subject was to be
             rescreened within 1 week.

          -  Serum creatinine ≥2.0 mg/dL.

          -  History of proliferative diabetic retinopathy OR any history of laser-treated
             retinopathy.

          -  History of treated peripheral or autonomic neuropathy.

          -  History of systolic dysfunction congestive heart failure.

          -  History of myocardial infarction within 1 year prior to Screening.

          -  History of ulcerative colitis or Crohn's disease.

          -  History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

          -  History of a psychiatric disorder that would affect the subject's ability to
             participate in the study.

          -  History of anaphylactic reaction(s) to any drug.

          -  History of angioedema.

          -  History of alcohol or substance abuse within the last 2 years.

          -  History of any surgery that could potentially affect the absorption of the study drug.

          -  Receipt of any investigational drug within the preceding 30 days or a history of
             receipt of an investigational antidiabetic drug within the preceding 90 days.