Phase 4
Completed N=286
Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01006590 ↗Enrolled (actual)
286
Serious AEs
4.2%
Results posted
Jan 2012
Primary outcomePrimary: Absolute Change From Baseline in HbA1c at Week 24 — -0.47; -0.38 Percent (%) — p=0.26
Summary
The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in HbA1c at Week 24 |
-0.47; -0.38 | 0.26 |
| SECONDARY Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0% |
43.8; 35.0 | 0.3202 |
| SECONDARY Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5% |
20.5; 16.8 | 0.6203 |
| SECONDARY Change From Baseline to Week 24 in Fasting Plasma Glucose |
-1.07; -1.14 | 0.7627 |
| SECONDARY Change From Baseline to Week 24 in Fasting Insulin |
-1.9; -2.3 | 0.7701 |
| SECONDARY Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta |
4.70; 2.34 | 0.5882 |
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent
- Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
- HbA1c ≥7.0% and ≤10.0%
Exclusion Criteria
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
- Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
- Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
Data sourced from ClinicalTrials.gov (NCT01006590). 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.