Phase 4
Completed N=720
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
Source: ClinicalTrials.gov NCT01006603 ↗Enrolled (actual)
720
Serious AEs
10.2%
Results posted
Nov 2013
Primary outcomePrimary: Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. — 37.9; 38.2; 39.2; 33.3 percentage of participants
Summary
This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. |
37.9; 38.2; 39.2; 33.3; 35.9; 45.5 | — |
| SECONDARY Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period. |
1.1; 15.3 | — |
| SECONDARY Change From Baseline to Week 52 in HbA1c. |
-0.44; -0.64 | — |
| SECONDARY Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0% |
44.7; 54.7 | — |
| SECONDARY Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) |
-0.73; -1.29 | — |
| SECONDARY Change From Baseline to Week 52 in Insulin |
-2.0; -0.6 | — |
| SECONDARY Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β] |
3.83; 16.22 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1
- HbA1c ≥7.0% and ≤9.0%
Exclusion Criteria
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.
- Renal impairment as defined by a creatinine clearance <60 mL/min
- 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 (NCT01006603). 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.