Phase 3
Completed N=640
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
Source: ClinicalTrials.gov NCT02273050 ↗Enrolled (actual)
640
Serious AEs
4.2%
Results posted
Feb 2018
Primary outcomePrimary: Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue — -3.007; -2.123; -2.794 % HbA1c — p=<0.001
◆ Published Evidence
Established
21citations · ~3 / year
Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial.
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 Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control
Linked Publications
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Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue |
-3.007; -2.123; -2.794 | <0.001 sig |
| SECONDARY Glycemic Response Defined as HbA1c < 7.0% at Week 24 |
81.8; 44.3; 71.1 | <0.001 sig |
| SECONDARY Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose |
-3.25; -1.86; -2.94 | <0.001 sig |
| SECONDARY Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test |
-1027.8; -611.9; -858.5 | <0.001 sig |
| SECONDARY Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24 |
67.0; 32.1; 55.4 | <0.001 sig |
| SECONDARY Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test |
-7.09; -4.12; -5.95 | <0.001 sig |
| SECONDARY Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase |
1.4; 10.3; 1.4 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- 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
- Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent corticosteroid treatment ; 3. Calculated creatinine clearance 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.
Data sourced from ClinicalTrials.gov (NCT02273050) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.