Phase 3
Completed N=420
Add-on to Thiazolidinedione (TZD) Failures
Source: ClinicalTrials.gov NCT00683878 ↗Enrolled (actual)
420
Serious AEs
1.7%
Results posted
Feb 2017
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) — -0.42; -0.82; -0.97 % of hemoglobin — p=0.0007
◆ Published Evidence
Highly cited
402citations · ~29 / year
Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy.
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 TZD alone. The safety of this treatment will also be studied
Linked Publications (4)
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Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy.
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The effect of dapagliflozin on renal function in patients with type 2 diabetes.
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) |
-0.42; -0.82; -0.97 | 0.0007 sig |
| SECONDARY Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) |
-14.1; -65.1; -67.5 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) |
1.64; 0.09; -0.14 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) |
-5.5; -24.9; -29.6 | <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]) |
22.4; 32.5; 38.8 | 0.0496 sig |
| SECONDARY Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF]) |
1.38; 0.52; -0.17 | 0.1566 |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]) |
1.83; 0.26; -0.07 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
- All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
- C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index ≤ 45.0 kg/m²
Exclusion Criteria
- AST and /or ALT > 2.5 times the upper limit of normal
- Serum total bilirubin > 2 mg/dL (34.2 µmol/L)
- Creatinine kinase > 3.0 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- Serum creatinine ≥ 2.0 mg/dL
- Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Data sourced from ClinicalTrials.gov (NCT00683878) and the linked publication. 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.