Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Alogliptin; Alogliptin placebo; Pioglitazone; Pioglitazone placebo
Intervention description: Alogliptin tablets.; Alogliptin placebo-matching tablets.; Pioglitazone tablets.; Pioglitazone placebo-matching tablets.
Intervention MeSH terms: Pioglitazone; Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1554.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Drug Therapy; Diabetes Mellitus, Non Insulin Dependent; Glucose Intolerance; Hyperglycemia

Summary:

      The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily
      (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated
             with metformin greater than or equal to 1500 mg alone but were experiencing inadequate
             glycemic control.

          -  A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated
             dose.

          -  No treatment with antidiabetic agents other than metformin within the 2 months prior
             to Screening.

          -  A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45
             kg/m^2.

          -  Fasting C-peptide greater than or equal to 0.8 ng/mL.

          -  Regular use of other, non-excluded medications was allowed if a stable dose had been
             established for at least 4 weeks prior to Screening.

          -  Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less
             than or equal to 100 mmHg.

          -  Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10
             g/dL for women.

          -  Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.

          -  Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.

          -  Thyroid-stimulating hormone level less than or equal to the upper limit of the normal
             range and the subject was clinically euthyroid.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             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 prohibited the patient
             from completing the study.

        Exclusion Criteria:

          -  Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.

          -  A history of cancer, other than squamous cell or basal cell carcinoma of the skin,
             that had not been in full remission for at least 5 years prior to Screening.

          -  A history of laser treatment for proliferative diabetic retinopathy within 6 months
             prior to Screening.

          -  A history of treated diabetic gastroparesis.

          -  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.

          -  History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.

          -  History of a psychiatric disorder that could have affected the patient's ability to
             participate in the study.

          -  History of angioedema in association with use of angiotensin-converting enzyme
             inhibitors or angiotensin-II receptor inhibitors.

          -  A history of alcohol or substance abuse within 2 years prior to Screening.

          -  Receipt of any investigational drug within 30 days prior to Screening or a history of
             receipt of an investigational antidiabetic drug within 3 months prior to Screening.

          -  Previous participation in an investigational study of alogliptin.

          -  Hypersensitive to pioglitazone, alogliptin, or other excipients.