Phase 3
Completed N=444
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Source: ClinicalTrials.gov NCT01095666 ↗Enrolled (actual)
444
Serious AEs
2.7%
Results posted
Sep 2017
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) — -0.23; -0.82; -0.85 % of hemoglobin — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are 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]) |
-0.23; -0.82; -0.85 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) |
0.5; -21.6; -26.6 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) |
-15.5; -57.8; -64.6 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) |
-0.74; -1.84; -2.56 | <0.0001 sig |
| SECONDARY Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) |
17.5; 32.9; 33.0 | 0.0010 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for 3 times ULN
- Serum total bilirubin > 2 mg/dL
- Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
- Creatine kinase ≥ 3 times 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 (NCT01095666). 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.