Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Alogliptin and Pioglitazone; Alogliptin; Placebo
Intervention description: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.; Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.; Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Intervention MeSH terms: Pioglitazone; 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: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy

Summary:

      The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by
      itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of type 2 diabetes

          -  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.

          -  Either failed treatment with diet and exercise for 3 months prior to Screening or has
             been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide
             for more than 3 months prior to Screening.

          -  Inadequate glycemic control as defined by glycosylated hemoglobin concentration
             between 6.5 and 9.0%, inclusive.

          -  Fasting plasma glucose less than 13.3 mmol per L.

          -  Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.

          -  Has not been receiving any lipid-lowering therapy within 3 months prior to Screening
             or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3
             months.

          -  Body mass index greater than 23 kg/m2 and less than 45 kg/m2.

          -  If has regular use of other, non-excluded medications, must be on a stable dose for at
             least 4 weeks prior to Screening. Use of as needed prescription medications and
             over-the-counter medications is allowed at the discretion of the investigator.

          -  Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to
             baseline.

        Exclusion Criteria

          -  History of type 1 diabetes.

          -  History of drug abuse (defined as illicit drug use) or a history of alcohol abuse
             (defined as regular or daily consumption of more than 4 alcoholic drinks per day)
             within the past 2 years.

          -  Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of
             greater than 160 mm Hg.

          -  History of cancer, other than basal cell carcinoma, that has not been in remission for
             at least 5 years prior to the first dose of study medication.

          -  Hemoglobin less than 120 g per L for males and less than100 g per L for females.

          -  Alanine transaminase level greater than 2.5 times the upper limit of normal, active
             liver disease, or jaundice.

          -  Serum creatinine level greater than 133 μmol per L.

          -  Fasting total cholesterol greater than 6.5 mmol per L.

          -  New York Heart Association heart failure of any Class (I-IV) regardless of therapy.

          -  History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or
             myocardial infarction within 6 months prior to Screening.

          -  History of acute metabolic diabetic complications.

          -  History of any hemoglobinopathy that may affect determination of glycosylated
             hemoglobin.

          -  History of infection with human immunodeficiency virus.

          -  History of diabetic gastro paresis.

          -  History of gastric bypass surgery.