Status:
COMPLETED
Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin...
Detailed Description
Allocation: Randomized Endpoint Classification: Efficacy/Safety study Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment
Eligibility Criteria
Inclusion
- 1\. Subjects with type 2 diabetes mellitus; 2. HbA1c ≥8% but ≤12%; 3.Fasting C-peptide ≥1.0 ng/ml; 4. Subject will be drug naïve; 5. Body mass index ≤40 kg/m2.
Exclusion
- 1\. Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent corticosteroid treatment ; 3. Calculated creatinine clearance \<60 ml/min or serum creatinine \>132.6 μmol/L (\>1.5 mg/dL) for men, \>123.8 μmol/L (\>1.4 mg/dL) for women; 4. Creatine Kinase ≥3x ULN; 5.Abnormal TSH value at screening will be further evaluated by free T4, subjects with an abnormal free T4 will be excluded; 6. History of administration of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive days or a total of seven non-consecutive days during the eight weeks prior to screening; 7. Current treatment with a strong CYP3A4/5 inhibitor; 8. Prior treatment with saxagliptin or any DPP-4 inhibitor; 9. Significant or history of cardiovascular disease, renal disease, psychiatric disorders, Immunocompromised individuals, hemoglobinopathies, liver disease, Pancreatitis.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
1136 Patients enrolled
Trial Details
Trial ID
NCT02273050
Start Date
December 1 2014
End Date
August 1 2016
Last Update
February 5 2018
Active Locations (17)
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1
Research Site
Beijing, China
2
Research Site
Changchun, China
3
Research Site
Chuangchun, China
4
Research Site
Fuzhou, China