Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Alogliptin and insulin; Alogliptin and insulin; Insulin
Intervention description: Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.; Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.; Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; 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: 390.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 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 determine the efficacy and safety of alogliptin, once daily
      (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of type 2 diabetes mellitus and currently treated with insulin alone (with
             or without metformin), and is inadequately controlled. Metformin dose must be stable
             for at least 8 weeks prior to Randomization.

          -  No treatment with antidiabetic agents other than insulin and metformin within the 8
             weeks prior to Randomization.

          -  Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2

          -  Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this
             screening criterion is not met, the subject still qualifies if C-peptide greater than
             or equal to 1.5 ng per mL after a challenge test).

          -  Glycosylated hemoglobin concentration greater than or equal to 8.0% at Screening.

          -  Using a stable dose of insulin of at least 15 units but not more than 100 units per
             day for at least 8 weeks prior to Randomization. A dose of insulin that varies by up
             to 15% of the mean will be considered as stable.

          -  If regular use of other, non-excluded medications, must be on a stable dose for at
             least the 4 weeks prior to Screening. However, as needed use of prescription or
             over-the-counter medications is allowed at the discretion of the investigator.

          -  Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less
             than or equal to 110 mm Hg

          -  Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal
             to10 g per dL for females.

          -  Alanine aminotransferase less than or equal to 3 times the upper limit of normal.

          -  Serum creatinine less than or equal to 2.0 mg per dL.

          -  Thyroid-stimulating hormone level less than or equal to the upper limit of the normal
             range and the subject is clinically euthyroid.

          -  Neither pregnant (confirmed by laboratory testing in females of childbearing
             potential) nor lactating.

          -  Female subjects of childbearing potential must be practicing adequate contraception.
             Adequate contraception must be practiced for the duration of participation in the
             study.

          -  Able and willing to monitor own blood glucose concentrations with a home glucose
             monitor

          -  No major illness or debility that in the investigator's opinion prohibits the
             individual from completing the study

          -  Able and willing to provide written informed consent

        Exclusion Criteria

          -  Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If
             elevated, the subject may be rescreened within 1 week.

          -  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. (History of
             treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II
             is allowed.).

          -  History of laser treatment for proliferative diabetic retinopathy within the 6 months
             prior to Screening.

          -  History of treated diabetic gastric paresis.

          -  New York Heart Association Class III or IV heart failure regardless of therapy.
             Currently treated subjects who are stable at Class I or II are candidates for the
             study.

          -  History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or
             myocardial infarction within the 6 months prior to Screening.

          -  History of any hemoglobinopathy that may affect determination of glycosylated
             hemoglobin.

          -  History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

          -  History of a psychiatric disorder that will affect ability to participate in the
             study.

          -  History of angioedema in association with use of angiotensin-converting enzyme
             inhibitors or angiotensin-II receptor inhibitors.

          -  History of alcohol or substance abuse within the 2 years prior to Screening.

          -  Receipt of any investigational drug within the 30 days prior to Screening or a history
             of receipt of an investigational antidiabetic drug within the 3 months prior to
             Screening.

          -  Prior treatment in an investigational study of alogliptin.

          -  Excluded Medications:

               -  Treatment with antidiabetic agents other than insulin and metformin is not
                  allowed within the 8 weeks prior to Randomization and through the completion of
                  the end-of treatment or early termination procedures. (Exception: if has received
                  other antidiabetic therapy for less than 7 days within the 3 months prior to
                  Screening.)

               -  Treatment with weight-loss drugs, any investigational antidiabetics, or oral or
                  systemically injected glucocorticoids is not allowed from 3 months prior to
                  randomization through the completion of the end-of-treatment or early termination
                  procedures. Inhaled corticosteroids are allowed.

               -  Must not take any medications, including over-the-counter products, without first
                  consulting with the investigator.