Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin 5mg; Placebo for Saxagliptin
Intervention description: Saxagliptin 5mg (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).; Placebo tablets (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Saxagliptin; Insulin, Short-Acting
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 953.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, Insulin, Dipeptidyl-Peptidase 4 Inhibitors, Metformin,saxagliptin,Endocrine System Diseases

Summary:

      A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety
      of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in
      Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on
      Insulin Alone or on Insulin in Combination with Metformin
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent before participating in the study.

          2. Diagnosed with type 2 diabetes.

          3. Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG<270 mg/dL
             (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG<270 mg/dL (15mmol/L)).

          4. On a stable dose of insulin for 8 weeks or longer prior to screening.

          5. If taking metformin, subjects should have been taking the same daily dose for 8 weeks
             or longer prior to screening.

          6. Insulin type should be intermediate-acting or long-acting (basal) or premixed
             (premixed formulation may include short- or rapid-acting insulin as one component).

          7. Body mass index ≤45 kg/m^2.

        Exclusion Criteria:

          1. Women of childbearing potential unable or unwilling to use acceptable birth control.

          2. Women who are pregnant or breastfeeding.

          3. Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria
             and polydipsia with greater than 10% weight loss during the last three months prior to
             screening or other signs and symptoms.

          4. Significant cardiovascular history defined as: myocardial infarction, coronary
             angioplasty or bypass graft, valvular disease or repair, unstable clinical significant
             arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular
             accident.

          5. Congestive heart failure

          6. Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable
             doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).

          7. History of unstable or rapidly progressing renal disease.

          8. History of alcohol or drug abuse within the previous year.

          9. Unstable major psychiatric disorders.

         10. History of hemoglobinopathies

         11. Immunocompromised status

         12. Severe liver disease.

         13. In subjects treated with insulin alone a calculated creatinine clearance <50 ml/min.
             In patients treated with insulin in combination with metformin a calculated creatinine
             clearance <60 ml/min or serum creatinine > 1.5 mg/dL in males or > 1.4mg/dL in
             females.

         14. Anemia