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

• Status: Completed
• Trial end date: 2016-02-26
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting; Metformin; Saxagliptin

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