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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02273050
• Date of registration: 22/10/2014
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: 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 Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
• Date of first enrolment: June 2014
• Target sample size: 1136
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02273050
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Changyu Pan, Professor
• Affiliation: The General Hospital of People's liberation Army

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

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.



Age minimum: 18 Years
Age maximum: 100 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Metformin 500 mg with titration

Drug: Placebo 500 mg for metformin (with titration)

Drug: Saxagliptin 5 mg

Drug: Placebo 5 mg for Saxagliptin

Primary Outcome(s)

The change in HbA1c from baseline to week 24(prior to rescue) [Time Frame: From baseline to week 24(prior to rescue)]

Secondary Outcome(s)

The change from baseline to Week 24 (prior to rescue) in 120-minute postprandial plasma glucose (PPG) in a subset of approximately 256 subjects [Time Frame: From baseline to week 24(prior to rescue)]

The proportion of subjects achieving a therapeutic glycaemic response defined as HbA1c =6.5% at Week 24 (prior to rescue) [Time Frame: From baseline to week 24(prior to rescue)]

The proportion of subjects achieving a glycaemic response(defined as HbA1c <7.0%) at week 24(prior to rescue) [Time Frame: From baseline to week 24(prior to rescue)]

The change in fasting plasma glucose (FPG) from baseline to Week 24 (prior to rescue) [Time Frame: From baseline to week 24(prior to rescue)]

The change from baseline to Week 24 (prior to rescue) in the Area Under Curve from 0 to 180 minutes for postprandial glucose (PPG) in response to a meal tolerance test in a subset of approximately 256 subjects [Time Frame: From baseline to week 24 (prior to rescue)]

The proportion of subjects requiring rescue for failing to achieve pre-specified glycaemic targets or discontinuing for lack of efficacy within the 24 weeks, double-blind treatment phase [Time Frame: From baseline to week 24 (prior to rescue)]

Secondary ID(s)

D1680C00009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors