Phase 3
Completed N=282
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00736879 ↗Enrolled (actual)
282
Serious AEs
1.4%
Results posted
May 2014
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants — 0.02; -0.68; -0.72; -0.82 Percent Hemoglobin — p=<0.0001
Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants |
0.02; -0.68; -0.72; -0.82 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants |
-0.96; -2.69; -2.64; -2.69 | 0.0018 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants |
4.1; -11.0; -21.6; -28.5 | 0.0103 sig |
| SECONDARY Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants |
8.81; -33.3; -39.3; -51.8 | <0.0001 sig |
| SECONDARY Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants |
34.6; 53.6; 43.4; 49.1 | 0.0157 sig |
| SECONDARY Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants |
-1.70; -2.50; -2.31; -3.17 | 0.3163 |
| SECONDARY Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants |
0; 0; 4; 0; 4; 1 | — |
| SECONDARY Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants |
0.8; -3.7; -3.1; -4.6; 0.2; -1.1 | — |
| SECONDARY Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants |
-1.3; -2.0; -1.6; -1.4 | — |
| SECONDARY Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants |
34; 38; 43; 38; 10; 5 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants |
0; 0; 1; 0; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
- Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
- C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index ≤ 45 kg/m²
- Must be able to perform self monitoring of blood glucose
Exclusion Criteria
- aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
- Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
- Creatinine kinase >3* ULN
- Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Data sourced from ClinicalTrials.gov (NCT00736879). 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.