Phase 3
Completed N=400
Evaluation of Dapagliflozin Taken Twice-daily
Source: ClinicalTrials.gov NCT01217892 ↗Enrolled (actual)
400
Serious AEs
1.8%
Results posted
Nov 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.52; -0.65; -0.59; -0.30 Percent — p=0.0106
Summary
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.52; -0.65; -0.59; -0.30 | 0.0106 sig |
| SECONDARY Adjusted Percent Change in Body Weight |
-2.84; -3.20; -2.76; -1.04 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1 |
-13.7; -14.7; -15.5; 2.0 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16 |
-20.8; -25.6; -20.4; -10.4 | 0.0010 sig |
| SECONDARY Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline. |
33.6; 38.2; 28.1; 21.4 | 0.0455 sig |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Diagnosis of T2DM
- Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
- HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.
Exclusion Criteria
- Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
- History of diabetic ketoacidosis
- Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
- FPG >270 mg/dL (>15.0 mmol/L)
- BMI >45 kg/m2
Data sourced from ClinicalTrials.gov (NCT01217892). 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.