Phase 4
Completed N=100
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Type II Diabetes
Source: ClinicalTrials.gov NCT02429258 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System — -18.2; 5.8 mg/dL — p=<0.001
◆ Published Evidence
Established
82citations · ~10 / year
Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial.
Summary
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Linked Publications
-
Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System |
-18.2; 5.8 | <0.001 sig |
| SECONDARY Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4 |
-10.0; 5.3 | 0.010 sig |
| SECONDARY Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population |
0.3; -0.6 | 0.023 sig |
| SECONDARY Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population |
12.2; -2.8 | <0.001 sig |
| SECONDARY Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population |
-12.6; 3.5 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4 |
-26.2; 3.6 | <0.001 sig |
| SECONDARY Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4 |
-50.9; -10.0 | <0.001 sig |
| SECONDARY Change in HbA1c From Baseline to Week 4 |
-0.51; -0.28 | 0.024 sig |
| SECONDARY Change in Fructosamine From Baseline to Week 4 |
-20.4; -9.6 | 0.019 sig |
| SECONDARY Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4 |
-49.5; -13.2 | <0.001 sig |
| SECONDARY Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population |
8.4; 1.4 | 0.017 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus (T2DM)
- Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
- Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
- Body mass index (BMI) 7 consecutive days during the 3 months prior to screening
- Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT02429258) 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.