Phase 3
Completed N=393
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Source: ClinicalTrials.gov NCT01095653 ↗Enrolled (actual)
393
Serious AEs
2.8%
Results posted
Feb 2017
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) — -0.29; -1.04; -1.11 % 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 This can indicate results are unpublished — a known publication-bias signal.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 improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. 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]) |
-0.29; -1.04; -1.11 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) |
2.5; -25.1; -31.6 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) |
1.08; -46.8; -54.9 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) |
-0.27; -1.64; -2.25 | <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]) |
21.3; 42.6; 49.8 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 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 (NCT01095653). 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.