Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Alogliptin; Rapid-acting insulin secretagogue
Intervention description: Alogliptin tablets; Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet
Intervention MeSH terms: Alogliptin; Insulin, Short-Acting; Secretagogues
Phase: Phase 3
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on
      to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2
      diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting
      insulin secretagogue as well as diet and exercise therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with type 2 diabetes mellitus.

          2. Had an HbA1c of ≥ 6.5% and < 10.0% at the start of the observation period (Week -2).

          3. Had been receiving specific diet and exercise (if applicable) therapies since at least
             10 weeks prior to the start of the observation period (Week -2).

          4. Had been receiving basic diabetes treatment with a rapid-acting insulin secretagogue
             (nateglinide or mitiglinide calcium hydrate) alone using a stable dosage regimen since
             at least 10 weeks prior to the start of the observation period (Week -2).

          5. Was suitable for combination therapy of either of the above rapid-acting insulin
             secretagogues (nateglinide or mitiglinide calcium hydrate) and another antidiabetic
             drug at the start of the observation period (Week -2) in the investigator's or
             subinvestigator's opinion.

          6. Participants complicated by hypertension had stable blood pressure control and needed
             neither dose adjustment of the ongoing antihypertensive (including discontinuation and
             interruption) nor additional use of another antihypertensive throughout the duration
             of the study in the investigator's or subinvestigator's opinion.

          7. Male or female and aged 20 years or older at the time of signing of informed consent.

          8. If female, and of child-bearing potential and sexually active with a nonsterilized
             male partner agreed to use adequate contraception routinely from signing of informed
             consent throughout the duration of the study.

          9. Visited the study site on an outpatient basis during the observation period.

         10. Was capable of understanding and complying with protocol requirements in the
             investigator's or subinvestigator's opinion.

         11. Signed and dated the informed consent documents prior to the start of any study
             procedures.

        Exclusion Criteria:

          1. Severe renal dysfunction or end-stage renal disease [e.g., a serum creatinine (SCr)
             level of >2.4 mg/dL (men) or >2.0 mg/dL (women) at the start of the observation period
             (Week -2)].

          2. Obvious clinical manifestations of hepatic impairment [e.g., an aspartate
             aminotransferase (AST) or alanine aminotransferase (ALT) value of ≥ 2.5 times the
             upper limit of normal at the start of the observation period (Week -2)].

          3. Any serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic
             or hematological disease (e.g., requiring hospitalization for treatment).

          4. Systolic blood pressure of ≥ 180 mmHg or diastolic blood pressure of ≥ 110 mmHg during
             the observation period.

          5. A condition requiring insulin for blood glucose control (e.g., a patient with severe
             ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, a pre-
             or post-operative condition, or serious trauma).

          6. Malignant tumor.

          7. History of hypersensitivity or allergies to dipeptidyl-peptidase-4 (DPP-4) inhibitors.

          8. A habitual drinker whose daily alcohol consumption was >100 mL on average.

          9. A history of drug abuse (defined as any illicit drug use) or alcohol abuse.

         10. Required to take excluded medications during the duration of the study.

         11. Previously received SYR-322 or Nesina® Tablets in a clinical study or as a therapeutic
             drug.

         12. Received any investigational product (including investigational products for
             postmarketing clinical studies) within 12 weeks prior to the start of the observation
             period.

         13. Had participated in another clinical study at signing of informed consent.

         14. If female, was pregnant or lactating, or intended to become pregnant between signing
             of informed consent and 1 month after the end of the study; or intended to donate ova
             during such time period.

         15. A study site employee, an immediate family member of a study site employee or in a
             dependent relationship with a study site employee who was involved in the conduct of
             this study (e.g., spouse, parent, child, sibling), or might consent under duress.

         16. Changed the dosing regimen of the ongoing rapid-acting insulin secretagogue during the
             observation period.

         17. History of hypersensitivity or allergies to rapid-acting insulin secretagogues.

         18. Any condition for which Nesina® Tablets, nateglinide, or mitiglinide calcium hydrate
             was contraindicated as defined in their package inserts.

         19. Otherwise ineligible for participation in the study in the investigator's or
             subinvestigator's opinion.