Phase 3
Completed N=596
Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT00680745 ↗Enrolled (actual)
596
Serious AEs
6.2%
Results posted
Oct 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.58; -0.63; -0.82; -0.13 Percent — p=<0.0001
Summary
This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.58; -0.63; -0.82; -0.13 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight |
-1.18; -1.56; -2.26; -0.72 | 0.1410 |
| SECONDARY Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise |
-37.5; -32.0; -34.9; -6.0 | 0.0002 sig |
| SECONDARY Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% |
26.8; 30.3; 31.7; 13.0 | 0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2 |
-1.17; -1.74; -2.47; -0.80 | 0.0262 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) |
-16.8; -21.2; -28.5; -2.0 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes
- Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
- Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
Exclusion Criteria
- Type 1 Diabetes
- Hepatic (liver) impairment
- Renal (kidney) failure or dysfunction
Data sourced from ClinicalTrials.gov (NCT00680745). 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.