Phase 3
Completed N=466
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
Source: ClinicalTrials.gov NCT02104804 ↗Enrolled (actual)
466
Serious AEs
5.6%
Results posted
Oct 2017
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24 — -0.64; -0.06 Percentage change — p=<0.001
◆ Published Evidence
Highly cited
15,387citations · ~308 / year
Prediction of creatinine clearance from serum creatinine.
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
Linked Publications (5)
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Prediction of creatinine clearance from serum creatinine.
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Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes.
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Dipeptidyl peptidase-4 inhibition and the treatment of type 2 diabetes: preclinical biology and mechanisms of action.
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Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes.
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Efficacy and safety of saxagliptin in drug-naïve Asian patients with type 2 diabetes mellitus: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24 |
-0.64; -0.06 | <0.001 sig |
| SECONDARY Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test |
-4702.2; 1431.0 | <0.001 sig |
| SECONDARY Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test |
-30.28; 8.84 | <0.001 sig |
| SECONDARY Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7% |
11.4; 3.5 | 0.002 sig |
| SECONDARY The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24) |
-11.23; 4.65 | <0.001 sig |
| SECONDARY Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24 |
-0.09; 0.04 | 0.430 |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent before participating in the study.
- Diagnosed with type 2 diabetes.
- Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG 1.5 mg/dL in males or > 1.4mg/dL in females.
- Anemia
Data sourced from ClinicalTrials.gov (NCT02104804) 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.