Phase 3
Completed N=807
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
Source: ClinicalTrials.gov NCT00673231 ↗Enrolled (actual)
807
Serious AEs
6.6%
Results posted
Aug 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.30; -0.75; -0.82; -0.90 Percent — p=<0.0001
Summary
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.30; -0.75; -0.82; -0.90 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight |
0.02; -0.98; -0.98; -1.67 | 0.0001 sig |
| SECONDARY Adjusted Mean Change in Calculated Mean Daily Insulin Dose |
5.08; -1.80; -0.61; -1.16 | <0.0001 sig |
| SECONDARY Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction |
11.0; 18.1; 16.8; 19.7 | 0.0427 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) |
3.3; -12.5; -18.8; -21.7 | 0.0008 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes
- Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs
Exclusion Criteria
- Type 1 Diabetes
- Treatment with more than two additional oral antidiabetic drugs
- Moderate and severe renal (kidney) failure or dysfunction
Data sourced from ClinicalTrials.gov (NCT00673231). 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.