Phase 3
Completed N=546
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Source: ClinicalTrials.gov NCT00528879 ↗Enrolled (actual)
546
Serious AEs
9.5%
Results posted
May 2014
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) — -0.30; -0.67; -0.70; -0.84 Percent — p=0.0002
Summary
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin 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]) |
-0.30; -0.67; -0.70; -0.84 | 0.0002 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF]) |
-6.0; -17.8; -21.5; -23.5 | <0.0019 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]) |
-0.89; -2.21; -3.04; -2.86 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) |
25.9; 33.0; 37.5; 40.6 | 0.1775 |
| SECONDARY Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF]) |
-0.53; -1.21; -1.37; -1.32 | 0.0068 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF]) |
-1.01; -2.39; -3.21; -3.09 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]) |
-0.31; -0.69; -0.71; -0.88 | 0.0004 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF]) |
1.2; -6.0; -12.0; -16.5 | <0.0001 sig |
| SECONDARY Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF]) |
13.8; 20.7; 14.5; 25.2 | 0.8627 |
Eligibility Criteria
Key Inclusion Criteria
- Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
- Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
- C-peptide ≥1.0 ng/mL
- Body mass index ≤45.0 kg/m^2
- Serum creatinine level 3.0 times the upper limit of normal
- Serum total bilirubin level >2 mg/dL
- Creatinine kinase level >3 times upper limit of normal
- Symptoms of severely uncontrolled diabetes
- Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
- Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases
Data sourced from ClinicalTrials.gov (NCT00528879). 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.