Phase 3
Completed N=598
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Source: ClinicalTrials.gov NCT00643851 ↗Enrolled (actual)
598
Serious AEs
3.7%
Results posted
Feb 2017
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) — -2.05; -1.19; -1.35 % of hemoglobin — p=<0.0001
Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. 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]) |
-2.05; -1.19; -1.35 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) |
-61.0; -42.0; -33.6 | <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]) |
52.4; 22.5; 34.6 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF]) |
-3.01; -1.67; -1.82 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) |
-2.66; -2.61; -1.29 | 0.8769 |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]) |
-3.04; -2.88; -1.47 | — |
Eligibility Criteria
Inclusion Criteria
- Males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for 3.0 times the upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL
- Creatine kinase > 3X the upper limit of normal (ULN)
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Data sourced from ClinicalTrials.gov (NCT00643851). 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.